Identity
- Device Name
- zDental Model EUDAMED
- Model / Reference
- zDental Model EUDAMED06971687881616 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971687881616 EUDAMED
- Basic UDI-DI
- 697168788ModelDB EUDAMED
- EMDN Code
- Q0102050101 TEMPORARY TEETH RESINS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Category: Dental appliance fabrication material, resin
zDental Model by Uniz Technology (Beijing) Co., Ltd. — 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 | 697168788ModelDB | Class I | Active |
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Manufacturer
- Manufacturer
- Uniz Technology (Beijing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000039351
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED a6c0916e-299e-4f29-97b3-7b1e34440f93 61 fields · synced Jul 31, 2026