{
  "resourceType": "StructureDefinition",
  "id": "device-registration",
  "url": "https://udi.anvisa.gov.br/fhir/StructureDefinition/UdiData",
  "version": "1.0.0",
  "name": "UdiData",
  "title": "UDI Data",
  "status": "draft",
  "description": "Representation of a device record instance in the UDI system",
  "fhirVersion": "5.0.0",
  "kind": "resource",
  "abstract": false,
  "type": "DeviceDefinition",
  "baseDefinition": "http://hl7.org/fhir/StructureDefinition/DeviceDefinition",
  "derivation": "constraint",
  "differential": {
    "element": [
      {
        "id": "DeviceDefinition",
        "path": "DeviceDefinition",
        "short": "Representation of a device registration instance in the UDI system"
      },
      {
        "id": "DeviceDefinition.extension",
        "path": "DeviceDefinition.extension",
        "min": 1
      },
      {
        "id": "DeviceDefinition.extension:refurbisherReprocessingCompany",
        "path": "DeviceDefinition.extension",
        "sliceName": "refurbisherReprocessingCompany",
        "short": "Refurbisher/Reprocessing Company's information",
        "max": "1",
        "type": [
          {
            "code": "Extension",
            "profile": [
              "https://udi.anvisa.gov.br/fhir/StructureDefinition/RefurbisherReprocessingCompany"
            ]
          }
        ]
      },
      {
        "id": "DeviceDefinition.extension:legalManufacturer",
        "path": "DeviceDefinition.extension",
        "sliceName": "legalManufacturer",
        "short": "Legal Manufacturer's information",
        "min": 1,
        "max": "1",
        "type": [
          {
            "code": "Extension",
            "profile": [
              "https://udi.anvisa.gov.br/fhir/StructureDefinition/LegalManufacturer"
            ]
          }
        ]
      },
      {
        "id": "DeviceDefinition.description",
        "path": "DeviceDefinition.description",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.identifier",
        "path": "DeviceDefinition.identifier",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.udiDeviceIdentifier",
        "path": "DeviceDefinition.udiDeviceIdentifier",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "property"
            }
          ],
          "rules": "open"
        },
        "min": 1,
        "max": "2"
      },
      {
        "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier",
        "path": "DeviceDefinition.udiDeviceIdentifier",
        "sliceName": "udiDeviceIdentifier",
        "short": "UDI-DI of the device",
        "min": 1,
        "max": "1"
      },
      {
        "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.extension",
        "path": "DeviceDefinition.udiDeviceIdentifier.extension",
        "max": "1"
      },
      {
        "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.extension:repurposingType",
        "path": "DeviceDefinition.udiDeviceIdentifier.extension",
        "sliceName": "repurposingType",
        "short": "Identification of the type of repurposing applied to this UDI-DI's device",
        "max": "1",
        "type": [
          {
            "code": "Extension",
            "profile": [
              "https://udi.anvisa.gov.br/fhir/StructureDefinition/RepurposingType"
            ]
          }
        ],
        "isModifier": false
      },
      {
        "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.deviceIdentifier",
        "path": "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier",
        "short": "The UDI-DI number associated with the device",
        "maxLength": 25
      },
      {
        "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.issuer",
        "path": "DeviceDefinition.udiDeviceIdentifier.issuer",
        "short": "The UDI-DI's issuer",
        "binding": {
          "strength": "required",
          "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/UDIIssuer"
        }
      },
      {
        "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.jurisdiction",
        "path": "DeviceDefinition.udiDeviceIdentifier.jurisdiction",
        "short": "The jurisdiction applied. By standard it's mandatory, but in this case will be ignored. Can be filled with the same value as the \"issuer\" field"
      },
      {
        "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.marketDistribution",
        "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution",
        "max": "1"
      },
      {
        "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.marketDistribution.marketPeriod.start",
        "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.start",
        "short": "Specify the date from which the company wishes the data to be made public. If left blank, the system will consider the submission date to publish the submitted information"
      },
      {
        "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.marketDistribution.marketPeriod.end",
        "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.end",
        "short": "Specify the date when the product will be discontinued, no longer offered on the market"
      },
      {
        "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.marketDistribution.subJurisdiction",
        "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction",
        "short": "National jurisdiction. By standard it's mandatory, but in this case will be ignored. Can be filled with the same value as the \"issuer\" field"
      },
      {
        "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal",
        "path": "DeviceDefinition.udiDeviceIdentifier",
        "sliceName": "udiDeviceIdentifierOriginal",
        "short": "UDI-DI of the original device who is being refurbished/reprocessed",
        "max": "1"
      },
      {
        "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.deviceIdentifier",
        "path": "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier",
        "short": "The UDI-DI number associated with the device",
        "maxLength": 25
      },
      {
        "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.issuer",
        "path": "DeviceDefinition.udiDeviceIdentifier.issuer",
        "short": "The UDI-DI's issuer",
        "binding": {
          "strength": "required",
          "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/UDIIssuer"
        }
      },
      {
        "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.jurisdiction",
        "path": "DeviceDefinition.udiDeviceIdentifier.jurisdiction",
        "short": "The jurisdiction applied. By standard it's mandatory, but in this case will be ignored. Can be filled with the same value as the \"issuer\" field"
      },
      {
        "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.marketDistribution",
        "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.regulatoryIdentifier",
        "path": "DeviceDefinition.regulatoryIdentifier",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "property"
            }
          ],
          "rules": "open"
        },
        "min": 1,
        "max": "2"
      },
      {
        "id": "DeviceDefinition.regulatoryIdentifier:premarketAuthorizationNumber",
        "path": "DeviceDefinition.regulatoryIdentifier",
        "sliceName": "premarketAuthorizationNumber",
        "short": "The Premarket Authorization Number seen in the Anvisa's product registration",
        "min": 1,
        "max": "1"
      },
      {
        "id": "DeviceDefinition.regulatoryIdentifier:premarketAuthorizationNumber.type",
        "path": "DeviceDefinition.regulatoryIdentifier.type",
        "short": "license | unit-of-use",
        "fixedCode": "license",
        "binding": {
          "strength": "required",
          "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/RegulatoryIdentifier|1.0.0"
        }
      },
      {
        "id": "DeviceDefinition.regulatoryIdentifier:premarketAuthorizationNumber.deviceIdentifier",
        "path": "DeviceDefinition.regulatoryIdentifier.deviceIdentifier",
        "maxLength": 11
      },
      {
        "id": "DeviceDefinition.regulatoryIdentifier:unitOfUseNumber",
        "path": "DeviceDefinition.regulatoryIdentifier",
        "sliceName": "unitOfUseNumber",
        "short": "The Unit of Use (UOU) DI Number - Identifier assigned to the individual medical device where UDI is not labeled at the unit of use level",
        "max": "1"
      },
      {
        "id": "DeviceDefinition.regulatoryIdentifier:unitOfUseNumber.type",
        "path": "DeviceDefinition.regulatoryIdentifier.type",
        "short": "license | unit-of-use",
        "fixedCode": "unit-of-use",
        "binding": {
          "strength": "required",
          "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/RegulatoryIdentifier|1.0.0"
        }
      },
      {
        "id": "DeviceDefinition.regulatoryIdentifier:unitOfUseNumber.deviceIdentifier",
        "path": "DeviceDefinition.regulatoryIdentifier.deviceIdentifier",
        "patternString": "[0-9]+",
        "maxLength": 23
      },
      {
        "id": "DeviceDefinition.partNumber",
        "path": "DeviceDefinition.partNumber",
        "short": "Catalog Number",
        "maxLength": 80
      },
      {
        "id": "DeviceDefinition.manufacturer",
        "path": "DeviceDefinition.manufacturer",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.deviceName",
        "path": "DeviceDefinition.deviceName",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "property"
            }
          ],
          "rules": "open"
        },
        "min": 2,
        "max": "2"
      },
      {
        "id": "DeviceDefinition.deviceName:brandName",
        "path": "DeviceDefinition.deviceName",
        "sliceName": "brandName",
        "short": "The Brand Name of the device (as indicated by the manufacturer)",
        "min": 1,
        "max": "1"
      },
      {
        "id": "DeviceDefinition.deviceName:brandName.name",
        "path": "DeviceDefinition.deviceName.name",
        "maxLength": 80
      },
      {
        "id": "DeviceDefinition.deviceName:brandName.type",
        "path": "DeviceDefinition.deviceName.type",
        "fixedCode": "user-friendly-name"
      },
      {
        "id": "DeviceDefinition.deviceName:tradeName",
        "path": "DeviceDefinition.deviceName",
        "sliceName": "tradeName",
        "short": "The Trade Name of the product (as seen in the Anvisa's regularization). This field is for query only",
        "max": "1"
      },
      {
        "id": "DeviceDefinition.deviceName:tradeName.name",
        "path": "DeviceDefinition.deviceName.name",
        "maxLength": 230
      },
      {
        "id": "DeviceDefinition.deviceName:tradeName.type",
        "path": "DeviceDefinition.deviceName.type",
        "fixedCode": "registered-name"
      },
      {
        "id": "DeviceDefinition.modelNumber",
        "path": "DeviceDefinition.modelNumber",
        "short": "Version or model",
        "min": 1,
        "maxLength": 80
      },
      {
        "id": "DeviceDefinition.classification",
        "path": "DeviceDefinition.classification",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "property"
            }
          ],
          "rules": "open"
        },
        "min": 1,
        "max": "3"
      },
      {
        "id": "DeviceDefinition.classification:gmdnTerm",
        "path": "DeviceDefinition.classification",
        "sliceName": "gmdnTerm",
        "short": "The GMDN nomenclature that characterizes the device",
        "min": 1,
        "max": "1"
      },
      {
        "id": "DeviceDefinition.classification:gmdnTerm.type",
        "path": "DeviceDefinition.classification.type",
        "binding": {
          "strength": "required",
          "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/GMDNTerm"
        }
      },
      {
        "id": "DeviceDefinition.classification:gmdnTerm.justification",
        "path": "DeviceDefinition.classification.justification",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.classification:riskClassification",
        "path": "DeviceDefinition.classification",
        "sliceName": "riskClassification",
        "short": "The risk classification of the product (as seen in the Anvisa's regularization). This field is for query only",
        "max": "1"
      },
      {
        "id": "DeviceDefinition.classification:riskClassification.type",
        "path": "DeviceDefinition.classification.type",
        "binding": {
          "strength": "required",
          "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/RiskClassification"
        }
      },
      {
        "id": "DeviceDefinition.classification:riskClassification.justification",
        "path": "DeviceDefinition.classification.justification",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.classification:anvisaNomenclature",
        "path": "DeviceDefinition.classification",
        "sliceName": "anvisaNomenclature",
        "short": "The Anvisa's nomenclature name (as seen in the Anvisa's regularization). This field is for query only",
        "max": "1"
      },
      {
        "id": "DeviceDefinition.classification:anvisaNomenclature.type",
        "path": "DeviceDefinition.classification.type",
        "binding": {
          "strength": "required",
          "valueSet": "https://udi.anvisa.gov.br/fhir/CodeSystem/AnvisaNomenclature"
        }
      },
      {
        "id": "DeviceDefinition.classification:anvisaNomenclature.justification",
        "path": "DeviceDefinition.classification.justification",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.conformsTo",
        "path": "DeviceDefinition.conformsTo",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.hasPart",
        "path": "DeviceDefinition.hasPart",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.packaging",
        "path": "DeviceDefinition.packaging",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "property"
            }
          ],
          "rules": "open"
        },
        "min": 1
      },
      {
        "id": "DeviceDefinition.packaging:primaryPackaging",
        "path": "DeviceDefinition.packaging",
        "sliceName": "primaryPackaging",
        "short": "Primary Packaging. Specifies the Quantity per Primary Packaging",
        "min": 1,
        "max": "1"
      },
      {
        "id": "DeviceDefinition.packaging:primaryPackaging.identifier",
        "path": "DeviceDefinition.packaging.identifier",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.packaging:primaryPackaging.type",
        "path": "DeviceDefinition.packaging.type",
        "short": "The identification of the primary packaging",
        "min": 1,
        "fixedCodeableConcept": {
          "coding": [
            {
              "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/PackagingLevel",
              "version": "1.0.0",
              "code": "1",
              "display": "Primary packaging"
            }
          ]
        },
        "binding": {
          "strength": "required",
          "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/PrimaryPackagingLevel"
        }
      },
      {
        "id": "DeviceDefinition.packaging:primaryPackaging.count",
        "path": "DeviceDefinition.packaging.count",
        "short": "Quantity per Primary Packaging",
        "min": 1,
        "minValueInteger": 1,
        "maxValueInteger": 999999999
      },
      {
        "id": "DeviceDefinition.packaging:primaryPackaging.distributor",
        "path": "DeviceDefinition.packaging.distributor",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.packaging:primaryPackaging.udiDeviceIdentifier",
        "path": "DeviceDefinition.packaging.udiDeviceIdentifier",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.packaging:primaryPackaging.packaging",
        "path": "DeviceDefinition.packaging.packaging",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.packaging:higherLevelsPackaging",
        "path": "DeviceDefinition.packaging",
        "sliceName": "higherLevelsPackaging",
        "short": "Identification of packaging beyond the primary packaging"
      },
      {
        "id": "DeviceDefinition.packaging:higherLevelsPackaging.identifier",
        "path": "DeviceDefinition.packaging.identifier",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.packaging:higherLevelsPackaging.type",
        "path": "DeviceDefinition.packaging.type",
        "short": "The Package Level",
        "min": 1,
        "binding": {
          "strength": "required",
          "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/HigherLevelsPackaging"
        }
      },
      {
        "id": "DeviceDefinition.packaging:higherLevelsPackaging.count",
        "path": "DeviceDefinition.packaging.count",
        "short": "The quantity per packaging",
        "min": 1,
        "minValueInteger": 1,
        "maxValueInteger": 999999999
      },
      {
        "id": "DeviceDefinition.packaging:higherLevelsPackaging.distributor",
        "path": "DeviceDefinition.packaging.distributor",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.packaging:higherLevelsPackaging.udiDeviceIdentifier",
        "path": "DeviceDefinition.packaging.udiDeviceIdentifier",
        "short": "The Package UDI-DI",
        "min": 1,
        "max": "1"
      },
      {
        "id": "DeviceDefinition.packaging:higherLevelsPackaging.packaging",
        "path": "DeviceDefinition.packaging.packaging",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.version",
        "path": "DeviceDefinition.version",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.safety",
        "path": "DeviceDefinition.safety",
        "short": "The MRI safety status. Specify the level of product safety in an operating magnetic resonance environment",
        "min": 1,
        "max": "1",
        "binding": {
          "strength": "required",
          "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/MRSafetyStatus"
        }
      },
      {
        "id": "DeviceDefinition.shelfLifeStorage",
        "path": "DeviceDefinition.shelfLifeStorage",
        "max": "1"
      },
      {
        "id": "DeviceDefinition.shelfLifeStorage.extension",
        "path": "DeviceDefinition.shelfLifeStorage.extension",
        "max": "1"
      },
      {
        "id": "DeviceDefinition.shelfLifeStorage.extension:specialPrecautionsForStorageDescription",
        "path": "DeviceDefinition.shelfLifeStorage.extension",
        "sliceName": "specialPrecautionsForStorageDescription",
        "short": "Specify storage and/or handling conditions that may directly impact the product's safety and efficacy",
        "max": "1",
        "type": [
          {
            "code": "Extension",
            "profile": [
              "https://udi.anvisa.gov.br/fhir/StructureDefinition/SpecialPrecautionsForStorageDescription"
            ]
          }
        ],
        "isModifier": false
      },
      {
        "id": "DeviceDefinition.shelfLifeStorage.type",
        "path": "DeviceDefinition.shelfLifeStorage.type",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.shelfLifeStorage.period[x]",
        "path": "DeviceDefinition.shelfLifeStorage.period[x]",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.shelfLifeStorage.specialPrecautionsForStorage",
        "path": "DeviceDefinition.shelfLifeStorage.specialPrecautionsForStorage",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.shelfLifeStorage.specialPrecautionsForStorage.text",
        "path": "DeviceDefinition.shelfLifeStorage.specialPrecautionsForStorage.text",
        "min": 1
      },
      {
        "id": "DeviceDefinition.languageCode",
        "path": "DeviceDefinition.languageCode",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.property",
        "path": "DeviceDefinition.property",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "property"
            }
          ],
          "rules": "open"
        }
      },
      {
        "id": "DeviceDefinition.property:deviceCategory",
        "path": "DeviceDefinition.property",
        "sliceName": "deviceCategory",
        "short": "Specify if the product corresponds to material, implantable material, equipment, implantable equipment, IVD, or SaMD",
        "min": 1,
        "max": "1"
      },
      {
        "id": "DeviceDefinition.property:deviceCategory.type",
        "path": "DeviceDefinition.property.type",
        "fixedCodeableConcept": {
          "coding": [
            {
              "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty",
              "version": "1.0.0",
              "code": "device-category",
              "display": "Medical Device Category"
            }
          ]
        }
      },
      {
        "id": "DeviceDefinition.property:deviceCategory.value[x]",
        "path": "DeviceDefinition.property.value[x]",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "binding": {
          "strength": "required",
          "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/DeviceCategory"
        }
      },
      {
        "id": "DeviceDefinition.property:singleUse",
        "path": "DeviceDefinition.property",
        "sliceName": "singleUse",
        "short": "Indicates if the device labeled as single-use",
        "min": 1,
        "max": "1"
      },
      {
        "id": "DeviceDefinition.property:singleUse.type",
        "path": "DeviceDefinition.property.type",
        "fixedCodeableConcept": {
          "coding": [
            {
              "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty",
              "version": "1.0.0",
              "code": "single-use",
              "display": "Device labeled as single-use"
            }
          ]
        }
      },
      {
        "id": "DeviceDefinition.property:singleUse.value[x]",
        "path": "DeviceDefinition.property.value[x]",
        "type": [
          {
            "code": "boolean"
          }
        ]
      },
      {
        "id": "DeviceDefinition.property:reusableDevice",
        "path": "DeviceDefinition.property",
        "sliceName": "reusableDevice",
        "short": "Indicates if the device is reusable",
        "min": 1,
        "max": "1"
      },
      {
        "id": "DeviceDefinition.property:reusableDevice.type",
        "path": "DeviceDefinition.property.type",
        "fixedCodeableConcept": {
          "coding": [
            {
              "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty",
              "version": "1.0.0",
              "code": "reusable-device",
              "display": "Reusable device"
            }
          ]
        }
      },
      {
        "id": "DeviceDefinition.property:reusableDevice.value[x]",
        "path": "DeviceDefinition.property.value[x]",
        "type": [
          {
            "code": "boolean"
          }
        ]
      },
      {
        "id": "DeviceDefinition.property:recommendedReprocessingCyles",
        "path": "DeviceDefinition.property",
        "sliceName": "recommendedReprocessingCyles",
        "short": "Specify the number of recommended reprocessing cycles",
        "max": "1"
      },
      {
        "id": "DeviceDefinition.property:recommendedReprocessingCyles.type",
        "path": "DeviceDefinition.property.type",
        "fixedCodeableConcept": {
          "coding": [
            {
              "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty",
              "version": "1.0.0",
              "code": "recommended-reprocessing-cyles",
              "display": "Number of reprocessing cycles recommended"
            }
          ]
        }
      },
      {
        "id": "DeviceDefinition.property:recommendedReprocessingCyles.value[x]",
        "path": "DeviceDefinition.property.value[x]",
        "type": [
          {
            "code": "Quantity"
          }
        ],
        "minValueQuantity": {
          "value": 1
        },
        "maxValueQuantity": {
          "value": 999999
        }
      },
      {
        "id": "DeviceDefinition.property:labeledAsSterile",
        "path": "DeviceDefinition.property",
        "sliceName": "labeledAsSterile",
        "short": "Indicates if the device is labeled as sterile",
        "min": 1,
        "max": "1"
      },
      {
        "id": "DeviceDefinition.property:labeledAsSterile.type",
        "path": "DeviceDefinition.property.type",
        "fixedCodeableConcept": {
          "coding": [
            {
              "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty",
              "version": "1.0.0",
              "code": "labeled-as-sterile",
              "display": "Device labeled as sterile"
            }
          ]
        }
      },
      {
        "id": "DeviceDefinition.property:labeledAsSterile.value[x]",
        "path": "DeviceDefinition.property.value[x]",
        "type": [
          {
            "code": "boolean"
          }
        ]
      },
      {
        "id": "DeviceDefinition.property:requiresSterilization",
        "path": "DeviceDefinition.property",
        "sliceName": "requiresSterilization",
        "short": "Indicates if the device requires sterilization before use",
        "max": "1"
      },
      {
        "id": "DeviceDefinition.property:requiresSterilization.type",
        "path": "DeviceDefinition.property.type",
        "fixedCodeableConcept": {
          "coding": [
            {
              "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty",
              "version": "1.0.0",
              "code": "requires-sterilization",
              "display": "Requires sterilization before use"
            }
          ]
        }
      },
      {
        "id": "DeviceDefinition.property:requiresSterilization.value[x]",
        "path": "DeviceDefinition.property.value[x]",
        "type": [
          {
            "code": "boolean"
          }
        ]
      },
      {
        "id": "DeviceDefinition.property:sterilizationMethod",
        "path": "DeviceDefinition.property",
        "sliceName": "sterilizationMethod",
        "short": "Sterilization method"
      },
      {
        "id": "DeviceDefinition.property:sterilizationMethod.type",
        "path": "DeviceDefinition.property.type",
        "fixedCodeableConcept": {
          "coding": [
            {
              "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty",
              "version": "1.0.0",
              "code": "sterilization-method",
              "display": "Sterilization Method"
            }
          ]
        }
      },
      {
        "id": "DeviceDefinition.property:sterilizationMethod.value[x]",
        "path": "DeviceDefinition.property.value[x]",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "binding": {
          "strength": "required",
          "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/SterilizationMethod"
        }
      },
      {
        "id": "DeviceDefinition.property:layUse",
        "path": "DeviceDefinition.property",
        "sliceName": "layUse",
        "short": "Indicates if the device can be used by a lay user",
        "max": "1"
      },
      {
        "id": "DeviceDefinition.property:layUse.type",
        "path": "DeviceDefinition.property.type",
        "fixedCodeableConcept": {
          "coding": [
            {
              "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty",
              "version": "1.0.0",
              "code": "lay-use",
              "display": "Intended for use by a lay user"
            }
          ]
        }
      },
      {
        "id": "DeviceDefinition.property:layUse.value[x]",
        "path": "DeviceDefinition.property.value[x]",
        "type": [
          {
            "code": "boolean"
          }
        ]
      },
      {
        "id": "DeviceDefinition.property:incorporatesAi",
        "path": "DeviceDefinition.property",
        "sliceName": "incorporatesAi",
        "short": "Indicates if the product incorporates AI (artificial intelligence) in any device function",
        "max": "1"
      },
      {
        "id": "DeviceDefinition.property:incorporatesAi.type",
        "path": "DeviceDefinition.property.type",
        "fixedCodeableConcept": {
          "coding": [
            {
              "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty",
              "version": "1.0.0",
              "code": "incorporates-ai",
              "display": "Incorporates Artificial Inteligence into the medical device function"
            }
          ]
        }
      },
      {
        "id": "DeviceDefinition.property:incorporatesAi.value[x]",
        "path": "DeviceDefinition.property.value[x]",
        "type": [
          {
            "code": "boolean"
          }
        ]
      },
      {
        "id": "DeviceDefinition.property:combinationProduct",
        "path": "DeviceDefinition.property",
        "sliceName": "combinationProduct",
        "short": "Indicates if the product is associated with any pharmaceutical product that has a secondary function in the device",
        "min": 1,
        "max": "1"
      },
      {
        "id": "DeviceDefinition.property:combinationProduct.type",
        "path": "DeviceDefinition.property.type",
        "fixedCodeableConcept": {
          "coding": [
            {
              "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty",
              "version": "1.0.0",
              "code": "combination-product",
              "display": "Combination product"
            }
          ]
        }
      },
      {
        "id": "DeviceDefinition.property:combinationProduct.value[x]",
        "path": "DeviceDefinition.property.value[x]",
        "type": [
          {
            "code": "boolean"
          }
        ]
      },
      {
        "id": "DeviceDefinition.property:clinicallyRelevantSizes",
        "path": "DeviceDefinition.property",
        "sliceName": "clinicallyRelevantSizes",
        "short": "Specify dimensional characteristics that are relevant for the product's clinical function",
        "max": "1"
      },
      {
        "id": "DeviceDefinition.property:clinicallyRelevantSizes.type",
        "path": "DeviceDefinition.property.type",
        "fixedCodeableConcept": {
          "coding": [
            {
              "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty",
              "version": "1.0.0",
              "code": "clinically-relevant-sizes",
              "display": "Clinically Relevant Sizes"
            }
          ]
        }
      },
      {
        "id": "DeviceDefinition.property:clinicallyRelevantSizes.value[x]",
        "path": "DeviceDefinition.property.value[x]",
        "type": [
          {
            "code": "string"
          }
        ],
        "maxLength": 5000
      },
      {
        "id": "DeviceDefinition.property:batchNumber",
        "path": "DeviceDefinition.property",
        "sliceName": "batchNumber",
        "short": "Indicates the presence of lot or Batch Number",
        "min": 1,
        "max": "1"
      },
      {
        "id": "DeviceDefinition.property:batchNumber.type",
        "path": "DeviceDefinition.property.type",
        "fixedCodeableConcept": {
          "coding": [
            {
              "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty",
              "version": "1.0.0",
              "code": "batch-number",
              "display": "Lot or Batch Number"
            }
          ]
        }
      },
      {
        "id": "DeviceDefinition.property:batchNumber.value[x]",
        "path": "DeviceDefinition.property.value[x]",
        "type": [
          {
            "code": "boolean"
          }
        ]
      },
      {
        "id": "DeviceDefinition.property:serialNumber",
        "path": "DeviceDefinition.property",
        "sliceName": "serialNumber",
        "short": "Indicates the presence of serial number",
        "min": 1,
        "max": "1"
      },
      {
        "id": "DeviceDefinition.property:serialNumber.type",
        "path": "DeviceDefinition.property.type",
        "fixedCodeableConcept": {
          "coding": [
            {
              "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty",
              "version": "1.0.0",
              "code": "serial-number",
              "display": "Serial Number"
            }
          ]
        }
      },
      {
        "id": "DeviceDefinition.property:serialNumber.value[x]",
        "path": "DeviceDefinition.property.value[x]",
        "type": [
          {
            "code": "boolean"
          }
        ]
      },
      {
        "id": "DeviceDefinition.property:expirationDate",
        "path": "DeviceDefinition.property",
        "sliceName": "expirationDate",
        "short": "Indicates the presence of expiration date",
        "min": 1,
        "max": "1"
      },
      {
        "id": "DeviceDefinition.property:expirationDate.type",
        "path": "DeviceDefinition.property.type",
        "fixedCodeableConcept": {
          "coding": [
            {
              "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty",
              "version": "1.0.0",
              "code": "expiration-date",
              "display": "Expiration date"
            }
          ]
        }
      },
      {
        "id": "DeviceDefinition.property:expirationDate.value[x]",
        "path": "DeviceDefinition.property.value[x]",
        "type": [
          {
            "code": "boolean"
          }
        ]
      },
      {
        "id": "DeviceDefinition.property:manufRecondReprocDate",
        "path": "DeviceDefinition.property",
        "sliceName": "manufRecondReprocDate",
        "short": "Indicates the presence of a Manufacture or Refurbishing/Reprocessing date",
        "min": 1,
        "max": "1"
      },
      {
        "id": "DeviceDefinition.property:manufRecondReprocDate.type",
        "path": "DeviceDefinition.property.type",
        "fixedCodeableConcept": {
          "coding": [
            {
              "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty",
              "version": "1.0.0",
              "code": "manuf-recond-reproc-date",
              "display": "Manufacture or Refurbishing/Reprocessing date"
            }
          ]
        }
      },
      {
        "id": "DeviceDefinition.property:manufRecondReprocDate.value[x]",
        "path": "DeviceDefinition.property.value[x]",
        "type": [
          {
            "code": "boolean"
          }
        ]
      },
      {
        "id": "DeviceDefinition.property:samdReleaseDate",
        "path": "DeviceDefinition.property",
        "sliceName": "samdReleaseDate",
        "short": "Indicates the presence of SaMD release date",
        "max": "1"
      },
      {
        "id": "DeviceDefinition.property:samdReleaseDate.type",
        "path": "DeviceDefinition.property.type",
        "fixedCodeableConcept": {
          "coding": [
            {
              "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty",
              "version": "1.0.0",
              "code": "samd-release-date",
              "display": "SaMD release date"
            }
          ]
        }
      },
      {
        "id": "DeviceDefinition.property:samdReleaseDate.value[x]",
        "path": "DeviceDefinition.property.value[x]",
        "type": [
          {
            "code": "boolean"
          }
        ]
      },
      {
        "id": "DeviceDefinition.property:samdVersion",
        "path": "DeviceDefinition.property",
        "sliceName": "samdVersion",
        "short": "Indicates the presence of SaMD version",
        "max": "1"
      },
      {
        "id": "DeviceDefinition.property:samdVersion.type",
        "path": "DeviceDefinition.property.type",
        "fixedCodeableConcept": {
          "coding": [
            {
              "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty",
              "version": "1.0.0",
              "code": "samd-version",
              "display": "SaMD version"
            }
          ]
        }
      },
      {
        "id": "DeviceDefinition.property:samdVersion.value[x]",
        "path": "DeviceDefinition.property.value[x]",
        "type": [
          {
            "code": "boolean"
          }
        ]
      },
      {
        "id": "DeviceDefinition.owner",
        "path": "DeviceDefinition.owner",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.contact",
        "path": "DeviceDefinition.contact",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "property"
            }
          ],
          "rules": "open"
        },
        "min": 1,
        "max": "2"
      },
      {
        "id": "DeviceDefinition.contact:urlForAdditionalInfo",
        "path": "DeviceDefinition.contact",
        "sliceName": "urlForAdditionalInfo",
        "short": "URL for additional information. Fill out whenever the company wants to indicate a URL where additional product information can be found (e.g., company website with product catalog or electronic instructions for use)",
        "max": "1"
      },
      {
        "id": "DeviceDefinition.contact:urlForAdditionalInfo.system",
        "path": "DeviceDefinition.contact.system",
        "min": 1,
        "fixedCode": "url"
      },
      {
        "id": "DeviceDefinition.contact:urlForAdditionalInfo.value",
        "path": "DeviceDefinition.contact.value",
        "min": 1,
        "maxLength": 5000
      },
      {
        "id": "DeviceDefinition.contact:urlForAdditionalInfo.use",
        "path": "DeviceDefinition.contact.use",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.contact:urlForAdditionalInfo.rank",
        "path": "DeviceDefinition.contact.rank",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.contact:urlForAdditionalInfo.period",
        "path": "DeviceDefinition.contact.period",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.contact:manufacCustomerServiceInfo",
        "path": "DeviceDefinition.contact",
        "sliceName": "manufacCustomerServiceInfo",
        "short": "Manufacturer’s Customer Service Contact Information (as indicated on the label)",
        "min": 1,
        "max": "1"
      },
      {
        "id": "DeviceDefinition.contact:manufacCustomerServiceInfo.system",
        "path": "DeviceDefinition.contact.system",
        "min": 1,
        "fixedCode": "other"
      },
      {
        "id": "DeviceDefinition.contact:manufacCustomerServiceInfo.value",
        "path": "DeviceDefinition.contact.value",
        "min": 1,
        "maxLength": 5000
      },
      {
        "id": "DeviceDefinition.contact:manufacCustomerServiceInfo.use",
        "path": "DeviceDefinition.contact.use",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.contact:manufacCustomerServiceInfo.rank",
        "path": "DeviceDefinition.contact.rank",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.contact:manufacCustomerServiceInfo.period",
        "path": "DeviceDefinition.contact.period",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.link",
        "path": "DeviceDefinition.link",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "property"
            }
          ],
          "rules": "open"
        },
        "max": "2"
      },
      {
        "id": "DeviceDefinition.link:attachedRecord",
        "path": "DeviceDefinition.link",
        "sliceName": "attachedRecord",
        "short": "Another registration to which this record is attached",
        "max": "1"
      },
      {
        "id": "DeviceDefinition.link:attachedRecord.relation",
        "path": "DeviceDefinition.link.relation",
        "fixedCoding": {
          "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/RelationType",
          "version": "1.0.0",
          "code": "attached",
          "display": "The current registration is being attached to another"
        },
        "binding": {
          "strength": "required",
          "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/AttachedRelationType"
        }
      },
      {
        "id": "DeviceDefinition.link:previousRecord",
        "path": "DeviceDefinition.link",
        "sliceName": "previousRecord",
        "short": "A previous registration replaced by this record",
        "max": "1"
      },
      {
        "id": "DeviceDefinition.link:previousRecord.relation",
        "path": "DeviceDefinition.link.relation",
        "binding": {
          "strength": "required",
          "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/PreviousRelationType"
        }
      },
      {
        "id": "DeviceDefinition.note",
        "path": "DeviceDefinition.note",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.material",
        "path": "DeviceDefinition.material",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "property"
            }
          ],
          "rules": "open"
        },
        "max": "2"
      },
      {
        "id": "DeviceDefinition.material:biologicMaterial",
        "path": "DeviceDefinition.material",
        "sliceName": "biologicMaterial",
        "short": "Indicates if any component of the product has origins in cells, tissues, or their non-viable derivatives (without metabolism or multiplication capability) or made non-viable",
        "max": "1"
      },
      {
        "id": "DeviceDefinition.material:biologicMaterial.substance",
        "path": "DeviceDefinition.material.substance",
        "fixedCodeableConcept": {
          "coding": [
            {
              "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/SubstanceType",
              "version": "1.0.0",
              "code": "biologic-material",
              "display": "Biological tissues/cells or their derivatives"
            }
          ]
        }
      },
      {
        "id": "DeviceDefinition.material:biologicMaterial.alternate",
        "path": "DeviceDefinition.material.alternate",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.material:biologicMaterial.allergenicIndicator",
        "path": "DeviceDefinition.material.allergenicIndicator",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.material:naturalLatex",
        "path": "DeviceDefinition.material",
        "sliceName": "naturalLatex",
        "short": "Indicates if the device is labeled as \"Contain natural latex. May cause allergy\"",
        "max": "1"
      },
      {
        "id": "DeviceDefinition.material:naturalLatex.substance",
        "path": "DeviceDefinition.material.substance",
        "fixedCodeableConcept": {
          "coding": [
            {
              "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/SubstanceType",
              "version": "1.0.0",
              "code": "natural-latex",
              "display": "Natural latex"
            }
          ]
        }
      },
      {
        "id": "DeviceDefinition.material:naturalLatex.alternate",
        "path": "DeviceDefinition.material.alternate",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.material:naturalLatex.allergenicIndicator",
        "path": "DeviceDefinition.material.allergenicIndicator",
        "min": 1,
        "fixedBoolean": true
      },
      {
        "id": "DeviceDefinition.productionIdentifierInUDI",
        "path": "DeviceDefinition.productionIdentifierInUDI",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.guideline.extension",
        "path": "DeviceDefinition.guideline.extension",
        "max": "1"
      },
      {
        "id": "DeviceDefinition.guideline.extension:warningDescription",
        "path": "DeviceDefinition.guideline.extension",
        "sliceName": "warningDescription",
        "short": "Additional critical warnings and contraindications for use",
        "max": "1",
        "type": [
          {
            "code": "Extension",
            "profile": [
              "https://udi.anvisa.gov.br/fhir/StructureDefinition/WarningDescription"
            ]
          }
        ],
        "isModifier": false
      },
      {
        "id": "DeviceDefinition.guideline.useContext",
        "path": "DeviceDefinition.guideline.useContext",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.guideline.usageInstruction",
        "path": "DeviceDefinition.guideline.usageInstruction",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.guideline.relatedArtifact",
        "path": "DeviceDefinition.guideline.relatedArtifact",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.guideline.indication",
        "path": "DeviceDefinition.guideline.indication",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.guideline.contraindication",
        "path": "DeviceDefinition.guideline.contraindication",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.guideline.warning",
        "path": "DeviceDefinition.guideline.warning",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.guideline.intendedUse",
        "path": "DeviceDefinition.guideline.intendedUse",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.correctiveAction",
        "path": "DeviceDefinition.correctiveAction",
        "max": "0"
      },
      {
        "id": "DeviceDefinition.chargeItem",
        "path": "DeviceDefinition.chargeItem",
        "max": "0"
      }
    ]
  }
}