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Dental Unit
EUDAMEDClass IIa (EU MDR)
Ref V5000Model S90/S60/S30/U100/U200/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 EUDAMEDV5000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974276290097 EUDAMED
- Basic UDI-DI
- 697427629000M8 EUDAMED
- Direct Marketing DI
- 06974276290097 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Luxembourg EUDAMEDAustria 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 6132d624-d7d6-460c-8e00-3d6461fa3d0c 61 fields · synced Jun 18, 2026
- EUDAMED 1ca5a7de-5567-478c-b1da-d548b8f34965 61 fields · synced Jun 18, 2026