This content applies to Device version: 1.1.0.0

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

Symbol	Meaning	Information
	Unique Device Identification	(01)8437025550005(10)1.0.0.0(11)YYYYMMDD
	Version	(10) 1.0.0.0
	Manufacture date	(11) YYYYMMDD
	Manufacturer	AI Labs Group SL BAT Tower, Gran Vía 1, 48001, Bilbao, Biscay (Spain)
	Authorised representative in Brazil	Brazil Import Healthcare Solutions Av. Octávio Gama, 1057, Bloco 19, 1901, 23.970-000, Caborê, Paraty, Rio de Janeiro (Brazil) 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

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.

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 Plus",
    "type": "user-friendly-name"
  },
  "version": "(10) 1.0.0.0",
  "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": "Class IIb according to EU MDR 2017/745",
  "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