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Only One Files
EUDAMEDClass IIa (EU MDR)
Ref D-P.01.04-021-06-040-GD-000-00-00Model Only One Files Gold 21mm R40 6pcs/packRef D-P.01.04-031-05-050-SR-000-00-00Model Only One Files 31mm R50 6pcs/packRef D-P.01.04-031-06-040-SR-000-00-00Model Only One Files 31mm R40 6pcs/packRef D-P.01.04-025-06-040-GD-000-00-00Model Only One Files Gold 25mm R40 6pcs/packRef D-P.01.04-021-VT-0A0-SR-000-00-00Model Only One Files 21mm R25-R50 6pcs/packRef D-P.01.04-025-05-050-SR-000-00-00Model Only One Files 25mm R50 6pcs/packRef D-P.01.04-031-06-040-GD-000-00-00Model Only One Files Gold 31mm R40 6pcs/packRef D-P.01.04-025-05-050-GD-000-00-00Model Only One Files Gold 25mm R50 6pcs/packRef D-P.01.04-021-VT-0A0-BU-000-00-00Model Only One Files Blue 21mm R25-R50 6pcs/packRef D-P.01.04-025-08-025-GD-000-00-00Model Only One Files Gold 25mm R25 6pcs/pack
Identity
- Trade Name
- Only One Files EUDAMED
- Device Name
- Only One Files EUDAMED
- Model / Reference
- Only One Files Gold 21mm R40 6pcs/pack EUDAMEDD-P.01.04-021-06-040-GD-000-00-00 EUDAMEDOnly One Files 31mm R50 6pcs/pack EUDAMEDD-P.01.04-031-05-050-SR-000-00-00 EUDAMEDOnly One Files 31mm R40 6pcs/pack EUDAMEDD-P.01.04-031-06-040-SR-000-00-00 EUDAMEDOnly One Files Gold 25mm R40 6pcs/pack EUDAMEDD-P.01.04-025-06-040-GD-000-00-00 EUDAMEDOnly One Files 21mm R25-R50 6pcs/pack EUDAMEDD-P.01.04-021-VT-0A0-SR-000-00-00 EUDAMEDOnly One Files 25mm R50 6pcs/pack EUDAMEDD-P.01.04-025-05-050-SR-000-00-00 EUDAMEDOnly One Files Gold 31mm R40 6pcs/pack EUDAMEDD-P.01.04-031-06-040-GD-000-00-00 EUDAMEDOnly One Files Gold 25mm R50 6pcs/pack EUDAMEDD-P.01.04-025-05-050-GD-000-00-00 EUDAMEDOnly One Files Blue 21mm R25-R50 6pcs/pack EUDAMEDD-P.01.04-021-VT-0A0-BU-000-00-00 EUDAMEDOnly One Files Gold 25mm R25 6pcs/pack EUDAMEDD-P.01.04-025-08-025-GD-000-00-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970514911908 EUDAMED06970514912110 EUDAMED06970514912103 EUDAMED06970514911878 EUDAMED06975718057490 EUDAMED06970514912080 EUDAMED06970514911939 EUDAMED06970514911885 EUDAMED06970514918617 EUDAMED06970514911854 EUDAMED
- Basic UDI-DI
- B-06970514911908 EUDAMEDB-06970514912110 EUDAMEDB-06970514912103 EUDAMEDB-06970514911878 EUDAMEDB-06975718057490 EUDAMEDB-06970514912080 EUDAMEDB-06970514911939 EUDAMEDB-06970514911885 EUDAMEDB-06970514918617 EUDAMEDB-06970514911854 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Only One Files by Shenzhen Denco Medical Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06970514911908 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Denco Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000014271
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (10)
- EUDAMED fd82d395-662e-49de-bf49-c1dc4bd857ef 61 fields · synced Sep 18, 2026
- EUDAMED 054d9da7-de5a-4a42-96fc-b12558f46bb6 61 fields · synced May 11, 2026
- EUDAMED dc8a20a4-bd3c-45c8-bef3-cc7d2892295d 61 fields · synced May 17, 2026
- EUDAMED 8f7e22a6-23cb-45f6-8589-39a95fa9b146 61 fields · synced May 17, 2026
- EUDAMED 6aba71f6-d23c-4316-854c-2e20425e467e 61 fields · synced May 18, 2026
- EUDAMED a98afa0b-6b4c-402d-9d27-16a7ded995d3 61 fields · synced May 19, 2026
- EUDAMED 01e7c663-9884-4ca0-8d3c-77fcb3de2a23 61 fields · synced May 19, 2026
- EUDAMED 5c26a51b-7f91-47aa-bdfa-1cdc5d078981 61 fields · synced May 19, 2026
- EUDAMED ec229d53-7a76-4875-b5a1-6b2ca1ffc71e 61 fields · synced May 19, 2026
- EUDAMED c7586a2c-43ed-4ec8-ae2b-1ffec2ea2cef 61 fields · synced May 19, 2026