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
	Version	(10) 2.1
	Manufacture date	(11) YYYYMMDD
	Manufacturer	AI Labs Group SL BAT Tower, Gran Vía 1, 48001, Bilbao, Biscay (Spain)

Symbol	Meaning
eIFU	Read the instructions before use
	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 should be reported to AI Labs Group S.L. as well as to the National Competent Authority of the country.
	CE marking per Council Directive 93/42/EEC
	Medical Device

Undesirable side-effects

It is not known or foreseen any undesirable side-effects specifically related to the use of the software.

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"
  }
}

Label in the device output​

Label in the device output