Identity
- Trade Name
- Silicone 3/4 Lenght Insole - L EUDAMED
- Device Name
- Orthopedic Support Products EUDAMED
- Model / Reference
- 593 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684084593034 EUDAMED
- Basic UDI-DI
- 8684084VM00001TF EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) 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 3/4 Lenght Insole - L 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 f9e54663-9dec-4da8-a872-af0156ffae63 61 fields · synced Jun 18, 2026