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Label

  • Device name: Legit.Health Plus
  • Unique Device Identifier (UDI): (01)8437025550005(10)1.0(11)YYYYMMDD
  • European Medical Device Nomenclature (EMDN) coding: Z12040192 (General medicine diagnosis and monitoring instruments - Medical device software)
  • Global Medical Device Nomenclature (GMDN) coding: 65975
  • Risk Classification according to EU MDR 2017/745: Class IIa
SymbolMeaningInformation
Version(10) 1.0
Manufacture date(11) YYYYMMDD
ManufacturerAI Labs Group SL
BAT Tower, Gran Vía 1, 48001, Bilbao, Biscay (Spain)
SymbolMeaning

eIFU		Read the instructions before use
In case of observing an incorrect operation of the software, notify the manufacturer as soon as possible: support@ legit.health. The manufacturer will proceed accordingly. Any serious incident should be reported to AI Labs Group S.L. as well as to the National Competent Authority of the country.

DRAFT		EU MDR 2017/745 CE marking (DRAFT)
Medical Device
Undesirable side-effects

It is not known or foreseen any undesirable side-effects specifically related to the use of the software.

Label in the device output​

Labelling information, including eIFU URL, are included in the output json file, under the section device:

{
    "resourceType": "Device",
    "typeOfDevice": "Medical Device",
    "manufacturer": {
      "name": "AI LABS GROUP SL",
      "address": "BAT Tower, Gran Vía 1, 48001, Bilbao, Biscay (Spain)"
    },
    "manufactureDate": "(11) 20231005 (YYYYMMDD)",
    "deviceName": {
      "name": "Legit.Health Plus",
      "type": "user-friendly-name"
    },
    "version": "(10) 1.0",
    "uniqueDeviceIdentifier": "(01)8437025550005(10)1.0(11)YYYYMMDD",
    "EMDNCoding": "Z12040192 (General medicine diagnosis and monitoring instruments - Medical device software)",
    "GMDNCoding": "65975",
    "eIFU": "Read the instructions before use https://apidocs.legit.health",
    "CEmark2797": "EU MDR 2017/745 CE marking (DRAFT). Notified Body 2797.",
    "riskClassification": "Class IIa according to EU MDR 2017/745",
    "warning": "In case of observing an incorrect operation of the software, notify the manufacturer as soon as possible: support@ legit.health. The manufacturer will proceed accordingly. Any serious incident related to the device must be reported both to the manufacturer and the competent authority in the Member State where the user or patient is located",
    "type": {
      "system": "http://snomed.info/sct",
      "code": "string",
      "display": "Dermatology picture archiving and communication system application software"
    }
}