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Dental Unit
EUDAMEDClass IIa (EU MDR)
Ref S60Model S90/S60/S30/U100/U200/U500/V1000/V2000/V5000/V6000Model S90/S60/S30/S70/U100/U200/U300/U500/V1000/V2000/V5000/V6000
Identity
- Trade Name
- Dental Unit EUDAMED
- Device Name
- Dental Unit EUDAMED
- Model / Reference
- S90/S60/S30/U100/U200/U500/V1000/V2000/V5000/V6000 EUDAMEDS60 EUDAMEDS90/S60/S30/S70/U100/U200/U300/U500/V1000/V2000/V5000/V6000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974276290028 EUDAMED
- Basic UDI-DI
- 697427629000M8 EUDAMED
- Direct Marketing DI
- 06974276290028 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Luxembourg EUDAMEDBelgium 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
Category: Dental delivery system
Dental Unit by Zhuhai Siger Medical Equipment Co., Ltd. — Class IIa — 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 | 697427629000M8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhuhai Siger Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000017163
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED c4db1c3a-4a99-4940-8ea2-e06e7db3fb2f 61 fields · synced Oct 7, 2026
- EUDAMED 2b44120e-3945-4468-94c5-cc0a18c54ea5 61 fields · synced Jun 11, 2026