Identity
- Trade Name
- Aluminum Polycentric Mechanical Hip Joint EUDAMED
- Device Name
- Prosthetic Knee-joints and Hip-joints EUDAMED
- Model / Reference
- 2-02-H1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04895200309246 EUDAMED
- Basic UDI-DI
- 48952003002RM6J EUDAMED
- EMDN Code
- Y062415 TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE 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
Category: Mechatronic external knee prosthesis
Aluminum Polycentric Mechanical Hip Joint by Regal Prosthesis Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 48952003002RM6J | 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 3afe535c-78ae-4e49-98c5-c3a17b7ce150 61 fields · synced Jul 8, 2026