Identity
- Trade Name
- Silverfox EUDAMED
- Device Name
- INTEGRAL DENTAL UNIT EUDAMED
- Model / Reference
- S8 Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973134776339 EUDAMED
- Basic UDI-DI
- 697313477S8ProSQ EUDAMED
- Direct Marketing DI
- 06973134776339 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 | 697313477S8ProSQ | 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 207a0996-6c9d-418a-8be3-cebcebb7b5c3 61 fields · synced Jun 9, 2026