Identity
- Trade Name
- Hinged Stabilizing Knee Brace - XL EUDAMED
- Device Name
- Orthopedic Products EUDAMED
- Model / Reference
- 828 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08692195828044 EUDAMED
- Basic UDI-DI
- 8692195VO00001VP EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Hinged Stabilizing Knee Brace - XL by Variteks Ortopedi Sanayi A.S. — 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 | 8692195VO00001VP | Class I | Active |
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Manufacturer
- Manufacturer
- Variteks Ortopedi Sanayi A.S.
- EUDAMED SRN
- TR-MF-000026919
Sources (1)
- EUDAMED e9ae9275-95a7-4949-adfd-d09705e29641 61 fields · synced Jul 29, 2026