Label
- Device name: Legit.Health Plus
- Unique Device Identifier (UDI): (01)8437025550005(10)1.0(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 EU MDR 2017/745: Class IIa
| Symbol | Meaning | Information |
|---|---|---|
| Version | (10) 1.0 | |
| 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. | |
| DRAFT | EU MDR 2017/745 CE marking (DRAFT) |
| Medical Device |
Undesirable side-effects
It is not known or foreseen any undesirable side-effects specifically related to the use of the software.