Identity
- Trade Name
- Zendura EUDAMED
- Device Name
- Zendura FLX and Zendura VIVA EUDAMED
- Model / Reference
- 9252 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850016682611 EUDAMED
- Basic UDI-DI
- 08500166820003G7 EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Zendura by Bay Materials LLC — 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 | 08500166820003G7 | Class I | Active |
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Manufacturer
- Manufacturer
- Bay Materials LLC
- EUDAMED SRN
- US-MF-000049150
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED a3723f78-17a5-4c7b-94ef-d8e2521d1bfb 61 fields · synced Jun 19, 2026