Identity
- Trade Name
- Silverfox EUDAMED
- Device Name
- INTEGRAL DENTAL UNIT EUDAMED
- Model / Reference
- S2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973134776315 EUDAMED
- Basic UDI-DI
- 697313477S2Z3 EUDAMED
- Direct Marketing DI
- 06973134776315 EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
Silverfox by Silverfox Corporation Limited — 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 | 697313477S2Z3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Silverfox Corporation Limited
- EUDAMED SRN
- CN-MF-000008252
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 79a8a29b-4e83-4113-b83e-d9d2f3820115 61 fields · synced Jun 9, 2026