Identity
- Trade Name
- RACE EUDAMED
- Device Name
- BIORACE EUDAMED
- Model / Reference
- 01.7B0.00.0EO.FK EUDAMED01.7B0.00.0AL.FK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640142411055 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
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Category: Manual endodontic file/rasp, reusable
The RACE device is a groundbreaking implantable medical device that offers unparalleled precision and reliability in dental implant placement. With its advanced technology and user-friendly interface, it has revolutionized the field of dentistry, providing doctors with a more accurate and efficient way to perform implants. But what makes the RACE truly unique? Let us delve into its key features to understand why it's a game-changer in the medical world.
Similar devices
Also classified as Manual endodontic file/rasp, reusable.
- K-Files 21mm 070, pu: 6 pcs — Diaswiss SA · Class I
- REAMERS — DiaDent Group International · Class I
- K-Files — MICRO MEGA · Class I
- Hand instrument K-file — TULSA DENTAL PRODUCTS LLC · Class I
- Endodontic Files — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class IIa
- ProFile .04 Taper Hand File — TULSA DENTAL PRODUCTS LLC · Class I
- KOMET Root Canal Files — Gebr. Brasseler GmbH & Co. KG · Class I
- Endodontic Files — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
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 b2a9d875-9cc8-423d-898d-31b003b2cea3 61 fields · synced Oct 8, 2026