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Silicone cosmetic prosthesis:Individual Innerhand:M, R, CM1
EUDAMEDClass I (EU MDR)
Ref SIH-M-R-CM1
Identity
- Trade Name
- Silicone cosmetic prosthesis:Individual Innerhand:M,R,CM1 EUDAMED
- Device Name
- Silicone Cosmetic Prostheses EUDAMED
- Model / Reference
- SIH-M-R-CM1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04895200370369 EUDAMED
- Basic UDI-DI
- 48952003007RX7Z EUDAMED
- EMDN Code
- Y061899 UPPER EXTREMITY PROSTHESES - OTHER 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 cosmetic prosthesis:Individual Innerhand:M, R, CM1 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 5e0c2dd3-496f-4b85-999d-2808b566fcce 61 fields · synced Aug 1, 2026