NOVATECH SA
FR-MF-000001658 · France · La Ciotat
NOVATECH SA is registered in the European database on medical devices as a manufacturer, with 91 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class IIa | 57 |
|---|---|
| Class IIb | 34 |
Most frequent device types declared: Tracheobronchial Stent.
Among these devices, 38 are declared sterile, 34 implantable, 16 reusable.
Devices declared under this manufacturer
- ROTEPS CLEANSE
- ROTEPS HANDLE
- ROTEPS HEAD
- ROTEPS SHAFT
- TRACHEOBRONXANE DUMON
Showing 12 of 91 declared devices.
Catalogue references include 02BRD1100, 02BRSW151, 02BRSW152, 02BRT10202, 02BRT10401, 02BRT30294.
European nomenclature codes declared: P0401, P0480, L031301, Z12020801, R9099, R070299.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | NOVATECH S.A. (FR) · FDA 9613846 |
| Devices in EUDAMED | 91 |
| Country of registration | France |
⚠️ A similar name exists; we do not assert it is the same company — why.
Device-level evidence
| Devices with a numeric GTIN | 91 |
|---|---|
| Found in the U.S. device database | 90 |
| Share | 98.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | NOVATECH SA |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1000317364 | supplemented | 2028-10-25 |