Identity
- Trade Name
- OppO genu X EUDAMED
- Device Name
- KNEE ORTHOSES EUDAMED
- Model / Reference
- 2935-R-L-O-BK-XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840270604504 EUDAMED
- Basic UDI-DI
- 08402706CL1134S 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
OppO genu X by OPPO Medical Inc. — 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 | 08402706CL1134S | Class I | Active |
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Manufacturer
- Manufacturer
- OPPO Medical Inc.
- EUDAMED SRN
- US-MF-000005202
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 4c26abfe-6200-4be0-a139-d74592b84eeb 61 fields · synced Jun 18, 2026