Label

Device name: Legit.Health
Unique Device Identifier (UDI): (01)8437025550005(10)2.1(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 Council Directive 93/42/EEC (MDD): Class I

Symbol	Meaning	Information
	Batch code (software version)	(10) 2.1
	Manufacture date	(11) YYYYMMDD
	Manufacturer	AI Labs Group SL BAT Tower, Gran Vía 1, 48001, Bilbao, Biscay (Spain)
	UK Responsible Person	APOTECH CONSULTING LIMITED 71-75 Shelton Street, London, WC2H 9JQ, England, United Kingdom

Symbol	Meaning
eIFU	Read the instructions before use: https://ifu-eu-mdd.legit.health
	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 to AI Labs Group SL as well as to the National Competent Authority of the country in which the user or patient is established. In the United Kingdom, serious incidents are reported to the Medicines and Healthcare products Regulatory Agency (MHRA) through the Yellow Card Scheme at https://yellowcard.mhra.gov.uk/ or by email to devices.regulatory@mhra.gov.uk.
	CE marking per Council Directive 93/42/EEC
	Medical Device

Undesirable side-effects

No undesirable side-effects specifically related to the use of the software are known or foreseen.

Document identification

Document version: this document is the instructions for use of Legit.Health version (10) 2.1.
Date of issue or latest revision: 26 August 2026. Minor revision.

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",
    "type": "user-friendly-name"
  },
  "version": "(10) 2.1",
  "uniqueDeviceIdentifier": "(01)8437025550005(10)2.1(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",
  "CEmark": "CE marking per Council Directive 93/42/EEC",
  "riskClassification": "Class I according to Council Directive 93/42/EEC (MDD)",
  "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"
  }
}

The eIFU is published at https://ifu-eu-mdd.legit.health. The address https://apidocs.legit.health that appears in the output above is a legacy address that redirects to it.

Document identification​

Label in the device output​

Document identification

Label in the device output