Novastep S.A.S.
FR-MF-000002428 · France · RENNES
Novastep S.A.S. is registered in the European database on medical devices as a manufacturer, with 354 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class IIa | 126 |
|---|---|
| Class IIb | 228 |
Among these devices, 238 are declared sterile, 228 implantable, 77 reusable.
Devices declared under this manufacturer
- PECA®
- PECA® 2.0
- PECA® 2.0 ø4
- Pecaplasty®
- Peca® Ø4
- Presslock®
- Tarsoplasty®
- airlock®
- arcad®
- arcad® 15
- arcad® 20
- arcad® 8
Showing 12 of 354 declared devices.
Catalogue references include CKW01004, CS011416, CS051818, SP012524, SP023008, SP024716.
European nomenclature codes declared: P09120503, L091002, V9012, P09120101, L091099.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | NOVASTEP (FR) · FDA 3010673777 |
| Devices in EUDAMED | 354 |
| 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 | 354 |
|---|---|
| Found in the U.S. device database | 238 |
| Share | 67.2 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
FR24/00000077 | supplemented | 2029-03-21 |