Identity
- Trade Name
- Director EUDAMED
- Device Name
- Director EUDAMED
- Model / Reference
- C1 200 50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961102700446 EUDAMED
- Basic UDI-DI
- 896110270ZI0707DP90002YN EUDAMED
- EMDN Code
- L150201 DENTAL RETRACTORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Director by Ziana Industries — 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 | 896110270ZI0707DP90002YN | Class I | Active |
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Manufacturer
- Manufacturer
- Ziana Industries
- EUDAMED SRN
- PK-MF-000011900
- Authorised Representative
- International Business Compendious of Sweden SE-AR-000001625
Sources (1)
- EUDAMED 3b582fae-3d43-4a83-aadd-bf6e2ba324b1 61 fields · synced Jun 19, 2026