Identity
- Device Name
- Dental Unit EUDAMED
- Model / Reference
- M8 EUDAMED321-210002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974416450268 EUDAMED
- Basic UDI-DI
- 697441645M8001BQ EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Dental Unit by Foshan Safety 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 | 697441645M8001BQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Foshan Safety Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000013172
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 77e8f7af-8980-4d48-b2ff-c2371009605b 61 fields · synced May 23, 2026