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POST
/
api
/
v1
/
submit
/
EU_UDI_IVDR
curl --request POST \
  --url https://api-preview.udiconnect.io/api/v1/submit/EU_UDI_IVDR \
  --header 'Authorization: <api-key>' \
  --header 'Content-Type: application/json' \
  --data '
{
  "device": {
    "IssuingAgency": "GS1",
    "Device": "00389524361706",
    "DeviceGroup": "439990216407HD",
    "BaseQuantity": 1,
    "CommercialDistributionStatus": "ON_THE_MARKET",
    "ProductionIdentifier": [
      "BATCH_NUMBER"
    ],
    "ReferenceNumber": "37588-474",
    "MDN": [
      "A0101010101"
    ],
    "NumberOfReuses": -1,
    "Sterile": false,
    "ReqSterilizatonPriorUse": true,
    "NewDevice": false,
    "MarketInfos": [
      {
        "Country": "DE",
        "OriginalPlacedOnTheMarket": true
      }
    ]
  },
  "deviceGroup": {
    "DeviceGroupAgency": "GS1",
    "DeviceGroup": "439990216407HD",
    "ApplicableLegislation": "IVDR",
    "MFActorCode": "DE-MF-000001723",
    "DeviceName": "p36 Test Device Name",
    "RiskClass": "CLASS_A",
    "AnimalTissuesCells": false,
    "HumanTissuesCells": false,
    "DeviceIntendedForSelfTesting": false,
    "DeviceIntendedForNearPatientTesting": false,
    "DeviceCompanionDiagnostics": false,
    "DeviceIntendedProfessionalTesting": false,
    "KitDevice": false,
    "Instrument": false,
    "Reagent": false,
    "DeviceContainsMicrobialSubstances": false
  }
}
'
{
  "agency": "EC",
  "requestId": "string",
  "modelInformation": "string",
  "status": "SUCCESS",
  "statusText": "Submission successfully validated and accepted"
}

Authorizations

​
Authorization
string
header
required

Body

application/json

Data to be submitted

​
actorCode
string
​
securityToken
string
​
authorizedRepresentativeCode
string
​
device
object

required for all EC submissions

​
deviceGroup
object

required for all EC submissions if not already submitted & published

Response

Submission Successful

Response for successful submission processing

​
agency
enum<string>

Regulatory agency information

Available options:
COMMON_DEVICE_DATA,
FDA,
EC,
NMPA,
MFDS,
GDSN,
SFDA,
TFDA,
TGA,
HSA
​
requestId
string

The unique identifier for the submission request

​
modelInformation
string

Information about the model and use case data used for processing the request

​
status
enum<string>

Submission response status

Available options:
INTERNAL_ERROR,
SUCCESS,
BLOCKED,
VALIDATION_FAILED,
INVALID_REQUEST
​
statusText
string

Submission response status text