Identity
- Trade Name
- RACE EUDAMED
- Device Name
- BIORACE EUDAMED
- Model / Reference
- 01.7B0.00.0EO.FK EUDAMEDS1.7B0.00.0CG.FK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640142414728 EUDAMED
- Basic UDI-DI
- 7640142410401029T EUDAMED
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Race 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 | 7640142410401029T | 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 (1)
- EUDAMED ec9b82b1-b172-46a2-95d6-f7e521dcb906 61 fields · synced Jun 17, 2026