Identity
- Trade Name
- NOVAWRIST EUDAMED
- Device Name
- NOVATHANE EUDAMED
- Model / Reference
- 03701422900950 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701422900950 EUDAMED
- Basic UDI-DI
- 37014229NOVATHANEHY EUDAMED
- EMDN Code
- M030504 IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPERATURES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Novawrist by Novatex Medical Sa — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 37014229NOVATHANEHY | Class I | Active |
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Manufacturer
- Manufacturer
- Novatex Medical Sa
- EUDAMED SRN
- FR-MF-000014276
Sources (1)
- EUDAMED abcd4f1b-1773-49c1-ae8f-dabdc96c1596 61 fields · synced Jun 18, 2026