← Back to catalogue
Dental Unit
EUDAMEDClass IIa (EU MDR)
Ref U500Model 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 EUDAMEDU500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974276290400 EUDAMED
- Basic UDI-DI
- 697427629000M8 EUDAMED
- Direct Marketing DI
- 06974276290400 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Luxembourg EUDAMEDItaly 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 — 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 | 697427629000M8 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
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 091fac72-bf9b-4954-b43d-9d5a57155990 61 fields · synced Jun 18, 2026
- EUDAMED 4e715de6-4eb8-4f90-94c2-6449ad0f8c05 61 fields · synced Jun 18, 2026