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Game Changer Universal Premium OA Knee Brace, Left
EUDAMEDClass I (EU MDR)
Ref 49001Model Game Changer OA Knee
Identity
- Trade Name
- Game Changer Universal Premium OA Knee Brace, Left EUDAMED
- Device Name
- Game Changer OA Knee EUDAMED
- Model / Reference
- Game Changer OA Knee EUDAMED49001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810047437031 EUDAMED
- Basic UDI-DI
- 081004743GCOAZE EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES 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
Game Changer Universal Premium OA Knee Brace, Left by Ovation Medical — 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 | 081004743GCOAZE | Class I | Active |
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Manufacturer
- Manufacturer
- Ovation Medical
- EUDAMED SRN
- US-MF-000051616
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED ed3b3bc4-211d-46ef-9f8d-ceeea52acebf 61 fields · synced Jul 12, 2026