Identity
- Trade Name
- Ankle Brace With Flexible Stays EUDAMED
- Device Name
- Orthopedic Products EUDAMED
- Model / Reference
- 897 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08692195897002 EUDAMED
- Basic UDI-DI
- 8692195VO00001VP EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT 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
Category: Ankle/foot orthosis
Ankle Brace With Flexible Stays by Variteks Ortopedi Sanayi A.S. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 | 8692195VO00001VP | Class I | Active |
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Manufacturer
- Manufacturer
- Variteks Ortopedi Sanayi A.S.
- EUDAMED SRN
- TR-MF-000026919
Sources (1)
- EUDAMED fc220900-d9bc-43c1-8090-71e378bfa776 61 fields · synced Oct 7, 2026