Identity
- Trade Name
- Silverfox EUDAMED
- Device Name
- INTEGRAL DENTAL UNIT EUDAMED
- Model / Reference
- 8000C-SRS0-E EUDAMED8000C-pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973134776124 EUDAMED
- Basic UDI-DI
- B-06973134776124 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Silverfox by Silverfox Corporation Limited — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06973134776124 | 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 8a9c3a13-6b9c-43cd-9688-b84e4bb8e8c1 61 fields · synced Jun 9, 2026