Identity
- Trade Name
- ZEYNİ EUDAMED
- Device Name
- INSTRUMENT COVER (FLOROSCOPY OR IMAGE INTENSIFIER COVER) 60X60 EUDAMED
- Model / Reference
- 107-003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682340123223 EUDAMED
- Basic UDI-DI
- 868234012107003JF EUDAMED
- EMDN Code
- T030101 COVER CAPS, INSTRUMENTS AND EQUIPMENT 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
Category: Vascular booties
Zeyni̇ by Zeyni Medikal Tekstil Insaat San. Ve Tic. Ltd. Sti — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 868234012107003JF | 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 395e17ce-012c-4234-a3db-cae558759543 61 fields · synced Jun 19, 2026