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Silicone Glove: 101LL, Male, Right, Size: CS
EUDAMEDClass I (EU MDR)
Ref 101LL-M-R-CS
Identity
- Trade Name
- Silicone Glove: 101LL, Male, Right, Size: CS EUDAMED
- Device Name
- Silicone Cosmetic Prostheses EUDAMED
- Model / Reference
- 101LL-M-R-CS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04895200318446 EUDAMED
- Basic UDI-DI
- 48952003007RX7Z EUDAMED
- EMDN Code
- Y061806 WRIST DISARTICULATION 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 Glove: 101LL, Male, Right, Size: CS 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 6b519457-40d1-4cac-b8ae-18c2924608c2 61 fields · synced Jul 9, 2026