Identity
- Trade Name
- ZEYNİ EUDAMED
- Device Name
- SMS EYE SURGERY DRAPE (SINGLE POUCH) 100X150 EUDAMED
- Model / Reference
- 108-031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682340123674 EUDAMED
- Basic UDI-DI
- 868234012108031JT EUDAMED
- EMDN Code
- T02010101 INCISION DRAPES, WITHOUT ANTIBACTERIAL AGENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
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
Zeyni̇ by Zeyni Medikal Tekstil Insaat San. Ve Tic. Ltd. Sti — 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 | 868234012108031JT | Class I | Active |
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Manufacturer
- Manufacturer
- Zeyni Medikal Tekstil Insaat San. Ve Tic. Ltd. Sti
- EUDAMED SRN
- TR-MF-000017474
Sources (1)
- EUDAMED a76855d4-a162-42fe-adaf-8c505c3d13aa 61 fields · synced Jun 19, 2026