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Irace
EUDAMEDClass IIa (EU MDR)
Ref 01.7B0.00.SAE.FKRef S1.7B0.00.SAE.FKRef 01.7B0.00.SAC.FKRef S1.7B0.00.SAB.FKRef 01.7B0.00.SAD.FKRef 01.7B0.00.SAA.FKRef S1.7B0.00.SAA.FK
Identity
- Trade Name
- IRACE EUDAMED
- Device Name
- IRACE EUDAMED
- Model / Reference
- 01.7B0.00.SAE.FK EUDAMEDS1.7B0.00.SAE.FK EUDAMED01.7B0.00.SAC.FK EUDAMEDS1.7B0.00.SAB.FK EUDAMED01.7B0.00.SAD.FK EUDAMED01.7B0.00.SAA.FK EUDAMEDS1.7B0.00.SAA.FK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640142411031 EUDAMED07640142411123 EUDAMED07640142411017 EUDAMED07640142411116 EUDAMED07640142411024 EUDAMED07640142410010 EUDAMED07640142414766 EUDAMED
- Basic UDI-DI
- B-07640142411031 EUDAMEDB-07640142411123 EUDAMEDB-07640142411017 EUDAMEDB-07640142411116 EUDAMEDB-07640142411024 EUDAMEDB-07640142410010 EUDAMEDB-07640142414766 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Manual endodontic file/rasp, reusable
Irace by FKG Dentaire Sàrl — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Manual endodontic file/rasp, reusable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07640142411031 | 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 58487b87-0465-4a2e-a748-71634cbcf568 61 fields · synced Jul 29, 2026
- EUDAMED a59e27db-f474-4f46-9f13-60499eee8b3e 61 fields · synced May 17, 2026
- EUDAMED 7b72336e-a84b-44f4-a7c9-9d7fedd39bd2 61 fields · synced May 17, 2026
- EUDAMED 45a14397-8b75-42b6-a1ff-7193b6aa71b4 61 fields · synced May 18, 2026
- EUDAMED 7b4d4775-d69d-456a-a1d3-ba9dd3b37fe7 61 fields · synced May 18, 2026
- EUDAMED 6c0f86ff-84c9-4f14-b5cc-09a3ad5bbea4 61 fields · synced May 19, 2026
- EUDAMED df6a2ae5-e649-4294-9d2f-3eb3ab5c029c 61 fields · synced May 19, 2026