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TRANSTIBIAL Silicone Cushion Liner – Forte
EUDAMEDClass I (EU MDR)
Ref 3-01-3020C-25
Identity
- Trade Name
- TRANSTIBIAL Silicone Cushion Liner – Forte EUDAMED
- Device Name
- Prosthetic Suspension Systems EUDAMED
- Model / Reference
- 3-01-3020C-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04895200309932 EUDAMED
- Basic UDI-DI
- 48952003003RP6V EUDAMED
- EMDN Code
- Y062409 TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE) 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
TRANSTIBIAL Silicone Cushion Liner – Forte 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 | 48952003003RP6V | 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 bfceec15-2fa0-4642-a15e-bdbdad02cd88 61 fields · synced Jul 8, 2026