Identity
- Device Name
- ROM-R EUDAMED
- Model / Reference
- U0460202300199 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03111790460244 EUDAMED
- Basic UDI-DI
- 311179FR0073AFA EUDAMED
- Direct Marketing DI
- 03111790460244 EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES 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
Rom-R by Thuasne — 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 | 311179FR0073AFA | Class I | Active |
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Manufacturer
- Manufacturer
- Thuasne
- EUDAMED SRN
- FR-MF-000001201
Sources (1)
- EUDAMED d6067c11-4cc5-4e7c-9948-e218c5cef81a 61 fields · synced Jul 18, 2026