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Prerace
EUDAMEDClass IIa (EU MDR)
Ref 01.7B0.00.0DB.FKRef 01.7B0.00.0DA.FKModel 01.7B0.00.0EO.FKRef 01.7B0.00.0DC.FKRef S1.7B0.00.0DF.FKRef S1.7B0.00.0DC.FKRef S1.7B0.00.0DB.FKRef 01.7B0.00.0DT.FK
Identity
- Trade Name
- PRERACE EUDAMED
- Device Name
- PRERACE EUDAMEDBIORACE EUDAMED
- Model / Reference
- 01.7B0.00.0DB.FK EUDAMED01.7B0.00.0EO.FK EUDAMED01.7B0.00.0DA.FK EUDAMED01.7B0.00.0DC.FK EUDAMEDS1.7B0.00.0DF.FK EUDAMEDS1.7B0.00.0DC.FK EUDAMEDS1.7B0.00.0DB.FK EUDAMED01.7B0.00.0DT.FK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640142411871 EUDAMED07640142411338 EUDAMED07640142411659 EUDAMED07640142413301 EUDAMED07640142413264 EUDAMED07640142413318 EUDAMED07640142411451 EUDAMED
- Basic UDI-DI
- B-07640142411871 EUDAMED7640142410401029T EUDAMEDB-07640142411659 EUDAMEDB-07640142413264 EUDAMEDB-07640142413318 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
EUDAMEDEUDAMED
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
Prerace by FKG Dentaire Sàrl — Class IIa — MDR, MDD — 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07640142411871 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07640142411871 | 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 (7)
- EUDAMED 4dfdb6f9-a86d-471a-801d-cff6770aac83 61 fields · synced Jul 30, 2026
- EUDAMED 15c64687-1b22-4571-97b0-47805a28dfcf 61 fields · synced May 11, 2026
- EUDAMED 609eee9c-f5b5-4b31-b153-6ee5623add9b 61 fields · synced May 16, 2026
- EUDAMED acb6bb06-8bb5-4872-a04f-0b16cc63dd5a 61 fields · synced May 17, 2026
- EUDAMED 9c5a42f4-afcc-485f-8819-c8801eb81463 61 fields · synced May 18, 2026
- EUDAMED b65f387f-d960-41d8-aa5f-ab47b49f10b7 61 fields · synced May 18, 2026
- EUDAMED cf93478c-b2e6-4a70-8da7-d8ececc3792c 61 fields · synced May 18, 2026