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Este conteúdo se aplica a versão do dispositivo: 1.1.0.0

Label

  • Nome do dispositivo: Legit.Health Plus
  • Codificação da Nomenclatura Europeia de Dispositivos Médicos (EMDN): Z12040192 (Instrumentos de diagnóstico e monitoramento de medicina geral - Software de dispositivo médico)
  • Codificação da Nomenclatura Global de Dispositivos Médicos (GMDN): 65975
  • Classificação de Risco de acordo com EU MDR 2017/745: Classe IIb
  • Classificação de Risco de acordo com Brasil RDC 751/2022: Classe II
SymbolMeaningInformação
Identificação Única do Dispositivo(01)8437025550005(10)1.1.0.0(11)AAAAMMDD
Versão(10) 1.1.0.0
Data de fabricação(11) AAAAMMDD
FabricanteLegit.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"
  }
}