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Dental Unit
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref U100Model S90/S60/S30/U100/U200/U500/V1000/V2000/V5000/V6000510(k) K142206
Identity
- Trade Name
- Dental Unit EUDAMED
- Device Name
- Dental Unit EUDAMED
- Model / Reference
- S90/S60/S30/U100/U200/U500/V1000/V2000/V5000/V6000 EUDAMEDU100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974276290042 EUDAMED
- Basic UDI-DI
- 697427629000M8 EUDAMED
- Direct Marketing DI
- 06974276290042 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Luxembourg 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
Dental Unit by Zhuhai Siger Medical Equipment Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142206 | Class IIa | Active |
| 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 (3)
- EUDAMED 2f1933e8-0b04-47da-b8fd-473bc00bcf2a 85 fields · synced Jun 19, 2026
- EUDAMED 2824ce61-914d-473b-b696-15ba7adf7ea2 61 fields · synced Jun 18, 2026
- FDA 510(k) K142206 1 fields · synced May 18, 2026