Identity
- Trade Name
- RACE EUDAMED
- Device Name
- BIORACE EUDAMED
- Model / Reference
- 01.7B0.00.0EO.FK EUDAMED01.7B0.00.0CE.FK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640142412328 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
No
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
Race 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 | 7640142410401029T | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- FKG Dentaire Sàrl
- EUDAMED SRN
- CH-MF-000017925
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED b6aa9785-7641-4841-9181-834b88d6bfcf 61 fields · synced Oct 5, 2026