HYGITECH
FR-MF-000007549 · France · Paris
HYGITECH is registered in the European database on medical devices as a manufacturer, with 80 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 80 |
|---|
Most frequent device types declared: Aspiration Cannulas, Aspiration System, Aspiration Tube, Irrigation System, Isolation and Surgical gowns.
Among these devices, 75 are declared sterile.
Devices declared under this manufacturer
- Essential Kit
- Non woven overshoes
- SET D'IRRIGATION M-M CHIROPRO/HERSEL
- SET D'IRRIGATION MASTER/ EXPERTSURG
- SET D'IRRIGATION POUR M-M SURGIC XT
- STERILE IRRIGATION SYSTEMS ELCOMED HYGI
- STERILE IRRIGATION SYSTEMS M-M ATR HYG
- SURGICAL GOWN WITH 2 HAND TOWELS M
- Sterile examination set
- Surgical Cannula 1.2mm tip
- Surgical Drape
- Surgical cap
Showing 12 of 80 declared devices.
Catalogue references include HY-12034, HY-500172, HY1-093, HY1-130012, HY1-3054, HY1-500132.
European nomenclature codes declared: T020102, T0202, A03040299, T020401, A06010103, Q010599.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 80 |
| Country of registration | France |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 80 |
|---|---|
| Found in the U.S. device database | 32 |
| Share | 40.0 % |
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: Neither register. HYGITECH was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
FR23/00000045 | supplemented | 2028-04-11 |