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This content applies to Device version: 1.1.0.0

Label

  • Device name: Legit.Health Plus
  • 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 IIb
  • Risk Classification according to Brasil RDC 751/2022: Class II
SymbolMeaningInformation
Unique Device Identification(01)8437025550005(10)1.1.0.0(11)YYYYMMDD
Version(10) 1.1.0.0
Manufacture date(11) YYYYMMDD
ManufacturerLegit.Health Legit.Health (AI Labs Group, SL) BAT Tower, Gran Vía 1, 48001, Bilbao, Biscay (Spain)
Authorised representative in BrazilBrasil Import Soluções para Saúde Ltda. Av. Cabore, N° 204-B, Sala 03 - Anexo Pousada Recanto dos Maddas, CEP 23970-000. Technical responsible: Claudia Carolina de Carvalho Mayer CRF/RJ 28.046
SymbolMeaning

eIFU		Consult electronic instructions for use
Caution

DRAFT		EU MDR 2017/745 CE marking (DRAFT)
Medical Device
ANVISARegistration # 81987060015
In case of observing an incorrect operation
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.
Undesirable side-effects
It is not known or foreseen any undesirable side-effects specifically related to the use of the software.

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) 1.1.0.0",
  "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": {
    "euMdr2017745": "Class IIb",
    "brRdc7512022": "Class II"
  },
  "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"
  }
}