Identity
- Trade Name
- Silicone Prosthetic toe EUDAMED
- Device Name
- Silicone Cosmetic Prostheses EUDAMED
- Model / Reference
- TOE3C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04895200316718 EUDAMED
- Basic UDI-DI
- 48952003007RX7Z EUDAMED
- EMDN Code
- Y062403 FOOT PARTIAL PROSTHESES (INCLUDING TOE PROSTHESES) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Silicone Prosthetic toe by Regal Prosthesis Limited — 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 | 48952003007RX7Z | Class I | Active |
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Manufacturer
- Manufacturer
- Regal Prosthesis Limited
- EUDAMED SRN
- HK-MF-000028642
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 4e3e7298-34a3-4392-8c12-64751818f99d 61 fields · synced Aug 1, 2026