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

Symbol	Meaning	Informação
	Identificação Única do Dispositivo	(01)8437025550005(10)1.1.0.0(11)AAAAMMDD
	Versão	(10) 1.1.0.0
	Data de fabricação	(11) 20260123
	Fabricante	Legit.Health Legit.Health (AI Labs Group, SL) BAT Tower, Gran Vía 1, 48001, Bilbao, Biscay (Spain)
	Authorised representative in Brazil	Brasil 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

Symbol	Meaning
eIFU	Consult electronic instructions for use
	Caution
DRAFT	EU MDR 2017/745 CE marking (DRAFT)
	Medical Device
ANVISA	Registration # 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:

{
  "deviceName": "Legit.Health Plus",
  "category": "Medical Device (MD)",
  "description": "Computational software-only medical device leveraging computer vision algorithms to process images of the epidermis, the dermis and its appendages, among other skin structures, providing an interpretative distribution of possible ICD categories and quantifiable data on the intensity, count, and extent of clinical signs.",
  "version": "1.1.0.0",
  "releaseDate": "2026-01-23",
  "manufacturer": {
      "name": "AI Labs Group S.L.",
      "description": "Digital health solutions developer specializing in AI-powered diagnostics",
      "countryCode": "ES",
      "website": "https://legit.health/"
  },
  "udi": "(01)8437025550005(10)1.1.0.0(11)20260123",
  "alternateIdentifiers": [
      {
          "system": "GMDN",
          "code": "65975",
          "issuingAuthority": "GMDN Agency",
          "description": "Global Medical Device Nomenclature identifier"
      },
      {
          "system": "EMDN",
          "code": "Z12040192",
          "issuingAuthority": null,
          "description": "European Medical Device Nomenclature code"
      }
  ],
  "standards": null,
  "regulatoryClearances": [
      {
          "regulation": "EU 2017/745",
          "riskClass": "Class IIb",
          "notifiedBody": "BSI Group (NB 2797)",
          "authorizationId": null,
          "authorizationDate": null
      }
  ],
  "claims": [
      {
          "description": "Users may request Instructions for Use in paper format at no additional cost within the EU territory.",
          "reference": "EU MDR 2017/745 Article 10(11)"
      },
      {
          "description": "30-day return policy for unused devices in original packaging.",
          "reference": "Internal Policy: RET-2024-001"
      }
  ],
  "precautions": [
      {
          "description": "Consult electronic instructions for use for detailed information on device operation and limitations.",
          "reference": "EU MDR 2017/745 Annex I, General safety and performance requirements Chapter III (Part 1) - Section 23.2(m)"
      }
  ],
  "contactEmail": "support@legit-health.com",
  "instructionsUrl": "https://apidocs-draft.legit.health/"
}