Identity
- Trade Name
- UNIZ EUDAMED
- Device Name
- zSG EUDAMED
- Model / Reference
- zSG Clear zSG Amber EUDAMEDzSG Clear EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971687880008 EUDAMED
- Basic UDI-DI
- 697168788zSG7H 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 | 697168788zSG7H | 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 e551ef96-1245-430a-aa61-521ab4a18894 61 fields · synced Jun 18, 2026