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Xp-4d
EUDAMEDClass IIa (EU MDR)
Ref S1.XB0.00.SAV.FKModel S1.XB0.00.0BD.FKRef S1.XB0.00.0BL.FKRef S1.XB0.00.0BT.FK
Identity
- Trade Name
- XP-4D EUDAMEDXP-4D STARTER EUDAMED
- Device Name
- XP-4D STARTER EUDAMED
- Model / Reference
- S1.XB0.00.0BD.FK EUDAMEDS1.XB0.00.SAV.FK EUDAMEDS1.XB0.00.0BL.FK EUDAMEDS1.XB0.00.0BT.FK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640452463577 EUDAMED07640142449959 EUDAMED07640452460033 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
Category: Manual endodontic file/rasp, reusable
Xp-4d by FKG Dentaire Sàrl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Manual endodontic file/rasp, reusable.
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- Endodontic Files — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class IIa
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 (3)
- EUDAMED fc08a421-b165-47c9-9c2c-e2a93deb6c21 61 fields · synced Oct 6, 2026
- EUDAMED 61c77c51-ebc8-4c08-8891-c2659bcb4b11 61 fields · synced May 16, 2026
- EUDAMED d783d17f-78d7-4eff-a88d-942352cb12a1 61 fields · synced May 17, 2026