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Edgefile X7
EUDAMEDClass IIa (EU MDR)
Ref X7170621HTSModel S1.7B0.00.0FI.FKRef X7300429HTSRef X7200621HTSRef X7350421HTSRef X7300625HTSRef X7250621HTSRef X70421ASSTRef X7200429HTSRef X70425ASSTRef X7450421HTSRef X7400429HTSRef X7450629HTSRef X7170421HTSRef X7300421HTSRef X7200425HTSRef X7300629HTSRef X7200421HTSRef X7300425HTSRef X7400621HTSRef X7300621HTSRef X7450429HTSRef X7170629HTSRef X70629ASSTRef X7400629HTSRef X7400625HTSRef X7250429HTSRef X7200625HTSRef X7350621HTS
Identity
- Trade Name
- EDGEFILE X7 EUDAMED
- Device Name
- R-Motion EUDAMED
- Model / Reference
- S1.7B0.00.0FI.FK EUDAMEDX7170621HTS EUDAMEDX7300429HTS EUDAMEDX7200621HTS EUDAMEDX7350421HTS EUDAMEDX7300625HTS EUDAMEDX7250621HTS EUDAMEDX70421ASST EUDAMEDX7200429HTS EUDAMEDX70425ASST EUDAMEDX7450421HTS EUDAMEDX7400429HTS EUDAMEDX7450629HTS EUDAMEDX7170421HTS EUDAMEDX7300421HTS EUDAMEDX7200425HTS EUDAMEDX7300629HTS EUDAMEDX7200421HTS EUDAMEDX7300425HTS EUDAMEDX7400621HTS EUDAMEDX7300621HTS EUDAMEDX7450429HTS EUDAMEDX7170629HTS EUDAMEDX70629ASST EUDAMEDX7400629HTS EUDAMEDX7400625HTS EUDAMEDX7250429HTS EUDAMEDX7200625HTS EUDAMEDX7350621HTS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640142449508 EUDAMED07640142449461 EUDAMED07640142449515 EUDAMED07640142449331 EUDAMED07640142449607 EUDAMED07640142449522 EUDAMED07640142449713 EUDAMED07640142449447 EUDAMED07640142449720 EUDAMED07640142449355 EUDAMED07640142449485 EUDAMED07640142449706 EUDAMED07640142449294 EUDAMED07640142449324 EUDAMED07640142449379 EUDAMED07640142449676 EUDAMED07640142449300 EUDAMED07640142449393 EUDAMED07640142449553 EUDAMED07640142449539 EUDAMED07640142449492 EUDAMED07640142449645 EUDAMED07640142449768 EUDAMED07640142449690 EUDAMED07640142449621 EUDAMED07640142449454 EUDAMED07640142449584 EUDAMED07640142449546 EUDAMED
- Basic UDI-DI
- 7640142410401019R EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Edgefile X7 by FKG Dentaire Sàrl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 7640142410401019R | 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 (28)
- EUDAMED 375641a0-8ba8-4330-b3d8-d51704e5f117 61 fields · synced Sep 30, 2026
- EUDAMED 481c51a9-fbcb-423c-b9d1-48a03d1c2e78 61 fields · synced May 11, 2026
- EUDAMED cc83cc18-8b42-4007-8d15-38e22bac6c75 61 fields · synced May 11, 2026
- EUDAMED aeac613b-6518-4bf2-80ff-156730ee84a3 61 fields · synced May 16, 2026
- EUDAMED bf671f05-5805-45ee-90cf-bbb4c2224269 61 fields · synced May 16, 2026
- EUDAMED f6ca43df-2ca3-4134-8c08-dbdb8fd0864c 61 fields · synced May 16, 2026
- EUDAMED 1c6181cb-6765-442c-b6df-c1ab087337bb 61 fields · synced May 16, 2026
- EUDAMED e1f8c5b5-3eb6-4768-aa72-aa41f7b9b9fa 61 fields · synced May 16, 2026
- EUDAMED 4dd1cb3d-a3d1-4fd7-af06-51f8e969353a 61 fields · synced May 17, 2026
- EUDAMED 69dd3e9d-df2b-423a-9e7a-2fcf031369f6 61 fields · synced May 17, 2026
- EUDAMED 56047357-38d7-488d-9b6b-800aa9c4cc48 61 fields · synced May 17, 2026
- EUDAMED 503e5ac3-2eb1-4c53-9235-dc79710c2da5 61 fields · synced May 17, 2026
- EUDAMED 7599432f-a18b-4e66-ae42-4d9e39b583db 61 fields · synced May 17, 2026
- EUDAMED 1a98780e-90d2-4a67-b65d-0e6675159775 61 fields · synced May 17, 2026
- EUDAMED 59d09880-4e13-4bf4-bdfc-dec277586918 61 fields · synced May 17, 2026
- EUDAMED fbb2458c-82bc-4459-8170-5b626d2284e9 61 fields · synced May 17, 2026
- EUDAMED 9e1855f8-acfd-445b-a3c7-caceaf063f70 61 fields · synced May 18, 2026
- EUDAMED e4051d40-80e1-41db-a2f8-f3f2fce96334 61 fields · synced May 18, 2026
- EUDAMED 79bda93a-9a28-4a78-a610-39a0753855f8 61 fields · synced May 18, 2026
- EUDAMED 7b37f5ff-29f1-491a-b269-1291519a986f 61 fields · synced May 18, 2026
- EUDAMED 831ef512-0448-4468-b72a-0d7581088b1c 61 fields · synced May 18, 2026
- EUDAMED e8bfd61f-5e1b-44ac-96b8-4f7e1329ea51 61 fields · synced May 18, 2026
- EUDAMED d7be8085-16c8-475b-8846-40fe08620683 61 fields · synced May 18, 2026
- EUDAMED cdcf226b-13fd-40e6-87b8-cedb8d55ed39 61 fields · synced May 19, 2026
- EUDAMED 655c2c6a-347c-451c-98d4-0047710f49d9 61 fields · synced May 19, 2026
- EUDAMED 2b883373-6785-49be-8e27-544b3abe93c4 61 fields · synced May 19, 2026
- EUDAMED 2bf18c05-6887-4867-9910-2ff7c597170f 61 fields · synced May 19, 2026
- EUDAMED 0c0b8de2-f696-4f66-a1a9-3ef8b36be1d2 61 fields · synced May 19, 2026