R-TF-001-008 Label

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

Symbol	Meaning	Information
	Unique Device Identification	(01)8437025550005(10)1.1.0.0(11)YYYYMMDD
	Version	(10) 1.1.0.0
	Manufacture date	(11) 20260123
	Manufacturer	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",
    "description": "The device is a computational software-only medical device leveraging computer vision algorithms to process images of the epidermis, the dermis and its appendages, among other skin structures. Its principal function is to provide a wide range of clinical data from the analyzed images to assist healthcare practitioners in their clinical evaluations and allow healthcare provider organisations to gather data and improve their workflows.",
    "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)00312345678901(17)251231(10)LOT123(21)SN9",
    "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": [
        {
            "standardName": "iso-14971",
            "standardVersion": "2019"
        },
        {
            "standardName": "iec-62304",
            "standardVersion": "2015"
        },
        {
            "standardName": "hl7-fhir",
            "standardVersion": "R5"
        }
    ],
    "regulatoryClearances": [
        {
            "regulation": "EU 2017/745",
            "riskClass": "Class IIb",
            "notifiedBody": "BSI Group (NB 2797)",
            "authorizationId": "CE-2024-12345",
            "authorizationDate": "2024-06-01"
        },
        {
            "regulation": "FDA",
            "riskClass": "Class II",
            "notifiedBody": null,
            "authorizationId": "K240001",
            "authorizationDate": "2024-08-15"
        }
    ],
    "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"
        }
    ],
    "contactEmail": "support@legit-health.com",
    "instructionsUrl": "https://apidocs-draft.legit.health/"
}

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

Author: Team members involved
Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & PRRC
Approver: JD-001 General Manager

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