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Uniz
EUDAMEDClass I (EU MDR)
Ref zDental IDBModel zDental IDB zDental IDB Hard zDental IDB SoftRef zDental Try-In A1Model zDental Try-In A1 zDental Try-In A2 zDental Try-In A3 zDental Try-In Bleach zDental Try-In BL1Ref zDental Tray
Identity
- Trade Name
- UNIZ EUDAMED
- Device Name
- zDental IDB EUDAMEDzDental Try-In EUDAMEDzDental Tray EUDAMED
- Model / Reference
- zDental IDB zDental IDB Hard zDental IDB Soft EUDAMEDzDental IDB EUDAMEDzDental Try-In A1 zDental Try-In A2 zDental Try-In A3 zDental Try-In Bleach zDental Try-In BL1 EUDAMEDzDental Try-In A1 EUDAMEDzDental Tray EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971687880411 EUDAMED06971687881210 EUDAMED06971687880817 EUDAMED
- Basic UDI-DI
- 697168788IDBWT EUDAMED697168788TryInA1GL EUDAMED697168788Tray8Z EUDAMED
- EMDN Code
- Q0102050101,Q0102050102,Q0102050199 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
Uniz by Uniz Technology (Beijing) Co., Ltd. — 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 | 697168788IDBWT | 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 (3)
- EUDAMED 9e1f2992-fe50-40be-bfb2-694789fd824f 61 fields · synced Aug 2, 2026
- EUDAMED bb8b37f7-29d2-479c-b772-67f8d0d9187c 61 fields · synced May 19, 2026
- EUDAMED 014c0535-47ff-4f68-86db-36973d13d7b0 61 fields · synced May 19, 2026