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Xp-4d Large
EUDAMEDClass IIa (EU MDR)
Ref S1.XB0.00.0CA.FKModel S1.XB0.00.0BD.FKRef S1.XB0.00.0BO.FKRef S1.XB0.00.0BS.FKRef S1.XB0.00.0BG.FK
Identity
- Trade Name
- XP-4D LARGE EUDAMED
- Device Name
- XP-4D STARTER EUDAMED
- Model / Reference
- S1.XB0.00.0BD.FK EUDAMEDS1.XB0.00.0CA.FK EUDAMEDS1.XB0.00.0BO.FK EUDAMEDS1.XB0.00.0BS.FK EUDAMEDS1.XB0.00.0BG.FK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640452460101 EUDAMED07640142449980 EUDAMED07640452460026 EUDAMED07640142449904 EUDAMED
- Basic UDI-DI
- 764014241050102A6 EUDAMED
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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
Xp-4d Large by FKG Dentaire Sàrl — 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 | 764014241050102A6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- FKG Dentaire Sàrl
- EUDAMED SRN
- CH-MF-000017925
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED 6d9f4f96-0208-42ba-8b15-42d76c7af0ca 61 fields · synced Oct 6, 2026
- EUDAMED ef1a27db-6945-4cc5-8a4f-41831cb98985 61 fields · synced May 16, 2026
- EUDAMED 1b49625c-4de2-4596-a101-d52193fc1d32 61 fields · synced May 18, 2026
- EUDAMED 62864b44-4780-4603-894d-02140c72f909 61 fields · synced May 18, 2026