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Race Evo
EUDAMEDClass IIa (EU MDR)
Ref S1.7B0.00.SCV.FKModel 01.7B0.00.0EO.FKRef S1.7B0.00.0GA.FKRef S1.7B0.00.0GD.FKRef S1.7B0.00.0GH.FKRef S1.7B0.00.0HH.FKRef S1.7B0.00.0GF.FKRef S1.7B0.00.0HB.FKRef S1.7B0.00.0DK.FKRef S1.7B0.00.0GI.FKRef S1.7B0.00.0DQ.FKRef S1.7B0.00.0DN.FKRef S1.7B0.00.0GE.FKRef S1.7B0.00.SCU.FKRef S1.7B0.00.0GG.FKRef S1.7B0.00.0HI.FKRef S1.7B0.00.0FW.FKRef S1.7B0.00.0DH.FKRef S1.7B0.00.0FY.FKRef S1.7B0.00.0DO.FKRef S1.7B0.00.SCY.FKRef S1.7B0.00.0GB.FKRef S1.7B0.00.0FX.FKRef S1.7B0.00.0GY.FKRef S1.7B0.00.0DI.FKRef S1.7B0.00.SDA.FKRef S1.7B0.00.0GJ.FKRef S1.7B0.00.0GZ.FKRef S1.7B0.00.0DL.FKRef S1.7B0.00.0GC.FKRef S1.7B0.00.0FZ.FKRef S1.7B0.00.0FV.FKRef S1.7B0.00.0DW.FKRef S1.7B0.00.0HD.FKRef 99.700.80.S03.FKRef S1.7B0.00.0DV.FK
Identity
- Trade Name
- RACE EVO EUDAMED
- Device Name
- BIORACE EUDAMED
- Model / Reference
- 01.7B0.00.0EO.FK EUDAMEDS1.7B0.00.SCV.FK EUDAMEDS1.7B0.00.0GA.FK EUDAMEDS1.7B0.00.0GD.FK EUDAMEDS1.7B0.00.0GH.FK EUDAMEDS1.7B0.00.0HH.FK EUDAMEDS1.7B0.00.0GF.FK EUDAMEDS1.7B0.00.0HB.FK EUDAMEDS1.7B0.00.0DK.FK EUDAMEDS1.7B0.00.0GI.FK EUDAMEDS1.7B0.00.0DQ.FK EUDAMEDS1.7B0.00.0DN.FK EUDAMEDS1.7B0.00.0GE.FK EUDAMEDS1.7B0.00.SCU.FK EUDAMEDS1.7B0.00.0GG.FK EUDAMEDS1.7B0.00.0HI.FK EUDAMEDS1.7B0.00.0FW.FK EUDAMEDS1.7B0.00.0DH.FK EUDAMEDS1.7B0.00.0FY.FK EUDAMEDS1.7B0.00.0DO.FK EUDAMEDS1.7B0.00.SCY.FK EUDAMEDS1.7B0.00.0GB.FK EUDAMEDS1.7B0.00.0FX.FK EUDAMEDS1.7B0.00.0GY.FK EUDAMEDS1.7B0.00.0DI.FK EUDAMEDS1.7B0.00.SDA.FK EUDAMEDS1.7B0.00.0GJ.FK EUDAMEDS1.7B0.00.0GZ.FK EUDAMEDS1.7B0.00.0DL.FK EUDAMEDS1.7B0.00.0GC.FK EUDAMEDS1.7B0.00.0FZ.FK EUDAMEDS1.7B0.00.0FV.FK EUDAMEDS1.7B0.00.0DW.FK EUDAMEDS1.7B0.00.0HD.FK EUDAMED99.700.80.S03.FK EUDAMEDS1.7B0.00.0DV.FK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640142425762 EUDAMED07640142426097 EUDAMED07640142426103 EUDAMED07640142425540 EUDAMED07640142425984 EUDAMED07640142425601 EUDAMED07640142426189 EUDAMED07640142425625 EUDAMED07640142425595 EUDAMED07640142425564 EUDAMED07640142425618 EUDAMED07640142425533 EUDAMED07640142425823 EUDAMED07640142426066 EUDAMED07640142425991 EUDAMED07640142425953 EUDAMED07640142425847 EUDAMED07640142426011 EUDAMED07640142425694 EUDAMED07640142425779 EUDAMED07640142425519 EUDAMED07640142425960 EUDAMED07640142426172 EUDAMED07640142425724 EUDAMED07640142425830 EUDAMED07640142425557 EUDAMED07640142426080 EUDAMED07640142425731 EUDAMED07640142425526 EUDAMED07640142425502 EUDAMED07640142425946 EUDAMED07640142425700 EUDAMED07640142426202 EUDAMED07640142414162 EUDAMED07640142425687 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 Evo by FKG Dentaire Sàrl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 (35)
- EUDAMED 9cbe191d-9274-41da-b164-b2757b3677a1 61 fields · synced Aug 4, 2026
- EUDAMED 31392dd1-b3af-4337-9686-d3d01a58f16d 61 fields · synced May 16, 2026
- EUDAMED 26e3c476-987b-4761-b6fd-5500b87b45a8 61 fields · synced May 16, 2026
- EUDAMED 1d27ec86-1b72-487c-b339-5b8112ffd27b 61 fields · synced May 16, 2026
- EUDAMED 3cb24209-f8e1-4712-867a-073a3d8ec412 61 fields · synced May 16, 2026
- EUDAMED 9ffaee12-3569-4477-a483-513c3cfe0af5 61 fields · synced May 16, 2026
- EUDAMED 74e1d852-4bab-4b3d-8e5a-2e0a18fffecc 61 fields · synced May 16, 2026
- EUDAMED 806b4e9f-1b50-40f1-bdf6-e6c48ccedfb5 61 fields · synced May 17, 2026
- EUDAMED 78bc4154-675b-42b2-97a4-188822669e1e 61 fields · synced May 17, 2026
- EUDAMED 2f4883d2-b511-4db3-91a2-52cbe4f58d58 61 fields · synced May 17, 2026
- EUDAMED 4cd1a3be-5575-4481-83ff-82aa298d3bdd 61 fields · synced May 17, 2026
- EUDAMED 9361572e-d815-4231-99ec-4275b941b278 61 fields · synced May 17, 2026
- EUDAMED 0554546a-c499-43cb-ad2f-d88dc63bb099 61 fields · synced May 17, 2026
- EUDAMED 8f580803-5c0a-49d9-bd48-1f9c6b9abbfb 61 fields · synced May 17, 2026
- EUDAMED 09bfd33d-6bed-4218-a913-0429d56eb8de 61 fields · synced May 17, 2026
- EUDAMED 7ead9adc-5d2c-4261-8ad7-e53636e3a0b1 61 fields · synced May 17, 2026
- EUDAMED 4e4046c9-1072-4dfd-9dfd-789c6fc46e51 61 fields · synced May 17, 2026
- EUDAMED 1d47a515-8e5f-4661-bf50-c40cc2348a6f 61 fields · synced May 17, 2026
- EUDAMED 2c8461a7-d927-46eb-8760-2b61f90b7005 61 fields · synced May 17, 2026
- EUDAMED 3e6027cc-031f-4931-aaea-df269834e5e6 61 fields · synced May 17, 2026
- EUDAMED 71b86e11-da85-4eeb-ab2d-e263abb1fe72 61 fields · synced May 17, 2026
- EUDAMED 087d27c5-2bfc-481c-8fe9-190ff19345b0 61 fields · synced May 18, 2026
- EUDAMED 8c545276-8751-40e5-aa7e-c70f903ea4d2 61 fields · synced May 18, 2026
- EUDAMED b817702d-0080-4f2c-a03a-d6cdb567e67f 61 fields · synced May 18, 2026
- EUDAMED 4f698fcf-8ebf-430c-865e-b334c47e30fe 61 fields · synced May 18, 2026
- EUDAMED 9675fee8-4729-466c-a287-c37b17c9fb12 61 fields · synced May 18, 2026
- EUDAMED 1fe376fc-31ae-4cf6-92b5-cb10258b80c4 61 fields · synced May 18, 2026
- EUDAMED b2cddbfa-bc0b-485a-89b9-46dcff3c0285 61 fields · synced May 18, 2026
- EUDAMED 3a0d0f3d-6f74-4828-9062-83665213a877 61 fields · synced May 18, 2026
- EUDAMED d7d66590-444c-493f-9538-06078d98b351 61 fields · synced May 18, 2026
- EUDAMED 5b4dd1a9-fa6b-4e8e-89a7-c2ea27dd6778 61 fields · synced May 18, 2026
- EUDAMED fe85268e-aff7-410c-b0c0-92766600ca9f 61 fields · synced May 18, 2026
- EUDAMED c978769a-5728-4594-bbde-f550b53cb14f 61 fields · synced May 19, 2026
- EUDAMED 743093a9-1de0-45ec-819a-5e82d29fd302 61 fields · synced May 19, 2026
- EUDAMED 7a76a5ae-b67a-4bbb-8b98-01f5de8da7bf 61 fields · synced May 19, 2026