FIM Medical
FR-MF-000017090 · France · Villeurbanne
FIM Medical is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 16 |
|---|
Most frequent device types declared: ADL20, Biocompatible earpad covers, Ergofilter SP1M, FF1075, Nose-clip.
Among these devices, 10 are declared active, 5 with a measuring function.
Devices declared under this manufacturer
- Audiolyser ADL20
- Earpad covers
- Ergofilter
- Pince Nez
- Qflow
- Spirolyser Q13
- TABATABA V2
- TABATABA V3
- VISIOLITE
- VISIOLITE MASTER Edition Computerized
- Visiolite Master GT
Showing 12 of 16 declared devices.
Catalogue references include FF1001, FF1006, FF1017, FF1037, FF1055, FF1075.
European nomenclature codes declared: Z1212012001, Z12150101, Z1399, V0399, V9099, Z12149080.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | FIM MEDICAL (FR) · FDA 3005053770 |
| Devices in EUDAMED | 16 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 16 |
|---|---|
| Found in the U.S. device database | 7 |
| Share | 43.8 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. FIM Medical is registered in the United States but was not found in the Canadian register.