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Reamers
EUDAMEDClass IIa (EU MDR)
Ref 01.160.21.006.CGModel 03.050.31.025.CTRef 01.160.25.060.CGRef 01.160.21.008.CGRef 01.160.31.050.CGRef 01.160.31.010.CGRef 01.160.21.070.CGRef 01.160.21.060.CGRef 01.160.25.035.CGRef 01.160.31.040.CGRef 01.160.21.040.CGRef 01.160.31.S15.CGRef 01.160.31.020.CGRef 01.160.25.040.CGRef 01.160.31.025.CGRef 01.160.31.008.CGRef 01.160.21.S06.CGRef 01.160.21.020.CGRef 01.160.21.045.CGRef 01.160.21.055.CGRef 01.160.21.S45.CGRef 01.160.31.060.CGRef 01.160.21.025.CGRef 01.160.25.050.CGRef 01.160.21.030.CGRef 01.160.25.010.CGRef 01.160.31.030.CGRef 01.160.31.080.CGRef 01.160.21.010.CGRef 01.160.31.055.CGRef 01.160.25.030.CG
Identity
- Trade Name
- REAMERS EUDAMED
- Device Name
- Barbed Broaches EUDAMEDSterile and non sterile reusable hand tools for root canal preparation during endodontic treatment EUDAMED
- Model / Reference
- 03.050.31.025.CT EUDAMED01.160.21.006.CG EUDAMED01.160.25.060.CG EUDAMED01.160.21.008.CG EUDAMED01.160.31.050.CG EUDAMED01.160.31.010.CG EUDAMED01.160.21.070.CG EUDAMED01.160.21.060.CG EUDAMED01.160.25.035.CG EUDAMED01.160.31.040.CG EUDAMED01.160.21.040.CG EUDAMED01.160.31.S15.CG EUDAMED01.160.31.020.CG EUDAMED01.160.25.040.CG EUDAMED01.160.31.025.CG EUDAMED01.160.31.008.CG EUDAMED01.160.21.S06.CG EUDAMED01.160.21.020.CG EUDAMED01.160.21.045.CG EUDAMED01.160.21.055.CG EUDAMED01.160.21.S45.CG EUDAMED01.160.31.060.CG EUDAMED01.160.21.025.CG EUDAMED01.160.25.050.CG EUDAMED01.160.21.030.CG EUDAMED01.160.25.010.CG EUDAMED01.160.31.030.CG EUDAMED01.160.31.080.CG EUDAMED01.160.21.010.CG EUDAMED01.160.31.055.CG EUDAMED01.160.25.030.CG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640142416104 EUDAMED07640142416647 EUDAMED07640142416111 EUDAMED07640142416883 EUDAMED07640142416807 EUDAMED07640142416340 EUDAMED07640142416326 EUDAMED07640142416548 EUDAMED07640142416869 EUDAMED07640142416258 EUDAMED07640142416890 EUDAMED07640142416821 EUDAMED07640142416562 EUDAMED07640142416838 EUDAMED07640142416791 EUDAMED07640142437338 EUDAMED07640142416173 EUDAMED07640142429616 EUDAMED07640142416302 EUDAMED07640142416395 EUDAMED07640142429630 EUDAMED07640142416197 EUDAMED07640142416609 EUDAMED07640142416210 EUDAMED07640142416449 EUDAMED07640142416845 EUDAMED07640142429654 EUDAMED07640142416135 EUDAMED07640142429623 EUDAMED07640142416524 EUDAMED
- Basic UDI-DI
- 7640142410301019E EUDAMED7640142410301029G EUDAMED
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMEDEUDAMED
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
Reamers by FKG Dentaire Sàrl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7640142410301019E | 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 (30)
- EUDAMED 17ca233f-ab71-4d0f-ac9a-e9e00c5517d6 61 fields · synced Sep 17, 2026
- EUDAMED 4320581d-6968-44a9-97ce-c5dbbd703e8e 61 fields · synced May 11, 2026
- EUDAMED 17f3160b-cae4-4f92-b33a-82c62390e848 61 fields · synced May 11, 2026
- EUDAMED f9e30689-aadd-4adc-993b-67481aab6649 61 fields · synced May 16, 2026
- EUDAMED 90f202ca-24c5-4ae1-8444-0f0dd3fb2651 61 fields · synced May 16, 2026
- EUDAMED d1ab8cf8-a851-4ec6-82ed-177a570993f5 61 fields · synced May 16, 2026
- EUDAMED 69f981c9-24c9-461a-9102-58d3973bf9e4 61 fields · synced May 16, 2026
- EUDAMED f087c155-f64a-45e1-a859-e021ca774f20 61 fields · synced May 16, 2026
- EUDAMED 44290017-d217-47bd-8497-36cb2a5bff3b 61 fields · synced May 16, 2026
- EUDAMED ba2a8dde-14e4-4f59-921a-778760b9d387 61 fields · synced May 16, 2026
- EUDAMED 5345d9ea-50e4-494c-8ebf-2db40a124ebc 61 fields · synced May 16, 2026
- EUDAMED 90152ba8-29f0-423d-ae59-0524c409307b 61 fields · synced May 17, 2026
- EUDAMED 33d49b80-17a9-4990-809f-f0e3653c1f0a 61 fields · synced May 17, 2026
- EUDAMED 63739f2c-8235-44e5-89c0-886ce215614f 61 fields · synced May 17, 2026
- EUDAMED 638c1150-e720-4430-8634-640dd67f66ad 61 fields · synced May 17, 2026
- EUDAMED 9221b622-95db-41c3-91bd-88252e2fb9c0 61 fields · synced May 17, 2026
- EUDAMED 917d407f-21a2-41ba-9ce9-7644cc7de478 61 fields · synced May 17, 2026
- EUDAMED 8487cce4-7ef8-42c6-8c32-cd32c9d0cb9c 61 fields · synced May 17, 2026
- EUDAMED 22feeb4c-2918-4197-93cb-4445817ad9ef 61 fields · synced May 17, 2026
- EUDAMED 8a54ec88-1816-4d01-b70e-4d022c1d0d66 61 fields · synced May 17, 2026
- EUDAMED c2162317-5468-4609-a861-b4c3495e7aeb 61 fields · synced May 18, 2026
- EUDAMED 659e7aec-bfac-4ad1-90b3-07f4b5b63e98 61 fields · synced May 18, 2026
- EUDAMED 80f97a2e-52c0-4235-867f-1b227dad745d 61 fields · synced May 18, 2026
- EUDAMED 22bc833f-f158-4bdd-9bef-672c8ad140ba 61 fields · synced May 19, 2026
- EUDAMED 3db95e92-6d9d-4626-9a13-3ccca641e0bd 61 fields · synced May 19, 2026
- EUDAMED 81c9bd1c-fede-4bc3-84ba-007976b624d8 61 fields · synced May 19, 2026
- EUDAMED df296ecf-288c-498b-9759-5185c2e49047 61 fields · synced May 19, 2026
- EUDAMED 929e0970-eb8a-403f-bc87-0738967ebe76 61 fields · synced May 19, 2026
- EUDAMED cc7f0ca3-54fb-4b5a-a06b-6f203523e021 61 fields · synced May 19, 2026
- EUDAMED d46ea249-d511-4a1e-b7cf-3ff37397ce02 61 fields · synced May 19, 2026