← Back to catalogue
W-Files
EUDAMEDClass IIa (EU MDR)
Ref D-P.01.10-025-08-025-SR-000-00-01Model W-Files 25mm Primary #025/08 3pcs/packRef D-P.01.10-025-08-040-SR-000-00-01Model W-Files 25mm Large #40/08 3pcs/packRef D-P.01.10-025-06-021-SR-000-00-01Model W-Files 25mm Small #021/06 3pcs/packRef D-P.01.10-025-VT-0A0-SR-000-00-01Model W-Files 25mm Small#021/06,Primary#025/08,Large#40/08 3pcs/packRef D-P.01.07-017-06-025-BU-000-00-00Model Primary Files 17mm 25#06 4pcs/packRef D-P.01.07-017-06-030-GD-000-00-00Model Primary Files Gold 17mm 30#06 4pcs/packRef D-P.01.07-017-04-025-BU-000-00-00Model Primary Files 17mm 25#04 4pcs/packRef D-P.01.07-017-06-020-GD-000-00-00Model Primary Files Gold 17mm 20#06 4pcs/pack
Identity
- Trade Name
- W-Files EUDAMEDPrimary Files EUDAMED
- Device Name
- W-Files EUDAMEDPrimary Files EUDAMED
- Model / Reference
- W-Files 25mm Primary #025/08 3pcs/pack EUDAMEDD-P.01.10-025-08-025-SR-000-00-01 EUDAMEDW-Files 25mm Large #40/08 3pcs/pack EUDAMEDD-P.01.10-025-08-040-SR-000-00-01 EUDAMEDW-Files 25mm Small #021/06 3pcs/pack EUDAMEDD-P.01.10-025-06-021-SR-000-00-01 EUDAMEDW-Files 25mm Small#021/06,Primary#025/08,Large#40/08 3pcs/pack EUDAMEDD-P.01.10-025-VT-0A0-SR-000-00-01 EUDAMEDPrimary Files 17mm 25#06 4pcs/pack EUDAMEDD-P.01.07-017-06-025-BU-000-00-00 EUDAMEDPrimary Files Gold 17mm 30#06 4pcs/pack EUDAMEDD-P.01.07-017-06-030-GD-000-00-00 EUDAMEDPrimary Files 17mm 25#04 4pcs/pack EUDAMEDD-P.01.07-017-04-025-BU-000-00-00 EUDAMEDPrimary Files Gold 17mm 20#06 4pcs/pack EUDAMEDD-P.01.07-017-06-020-GD-000-00-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970514910208 EUDAMED06970514918754 EUDAMED06970514911632 EUDAMED06970514918938 EUDAMED06970514918228 EUDAMED06942512501818 EUDAMED06970514918211 EUDAMED06942512501801 EUDAMED
- Basic UDI-DI
- B-06970514910208 EUDAMEDB-06970514918754 EUDAMEDB-06970514911632 EUDAMEDB-06970514918938 EUDAMEDB-06970514918228 EUDAMEDB-06942512501818 EUDAMEDB-06970514918211 EUDAMEDB-06942512501801 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
W-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-06970514910208 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Denco Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000014271
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (8)
- EUDAMED 96781934-150e-443e-9f3e-f2faa9b5fdad 61 fields · synced Aug 2, 2026
- EUDAMED 37182c53-c816-4554-973b-09413face7a9 61 fields · synced May 17, 2026
- EUDAMED c4d8e2ca-a354-486b-a8b0-c277be898f63 61 fields · synced May 18, 2026
- EUDAMED bc002ecb-e903-433c-b970-f73000f31c14 61 fields · synced May 19, 2026
- EUDAMED 80f827b8-23fb-43ae-a5dd-000f9be55ab4 61 fields · synced Jul 15, 2026
- EUDAMED 50ebeff3-a1e6-41e3-af00-4a45cc3f2dd7 61 fields · synced Jul 19, 2026
- EUDAMED b7c04291-6d2d-499a-b30f-7711bd115f1a 61 fields · synced Jul 20, 2026
- EUDAMED cab9e7e1-0227-4b87-b401-02d9cb0c6638 61 fields · synced Jul 26, 2026