Identity
- Trade Name
- Silicone Forefoot Insole EUDAMED
- Device Name
- Orthopedic Support Products EUDAMED
- Model / Reference
- 549 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684084549000 EUDAMED
- Basic UDI-DI
- 8684084VM00001TF EUDAMED
- EMDN Code
- V080399 MEDICAL CUSHIONS - OTHER 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
Silicone Forefoot Insole by Variteks Medikal Sanayi Ve Ticaret 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 | 8684084VM00001TF | Class I | Active |
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Manufacturer
- Manufacturer
- Variteks Medikal Sanayi Ve Ticaret A.S.
- EUDAMED SRN
- TR-MF-000048979
Sources (1)
- EUDAMED fbcf05dc-c741-4e6e-a2fc-2516b58b1432 61 fields · synced Oct 6, 2026