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S.S.K-Files MM mark
EUDAMEDClass IIa (EU MDR)
Ref D-P.02.01-031-02-0A1-SR-000-00-mmModel S.S.K-Files MM mark 31mm #45-80 6pcs/packRef D-P.02.01-021-02-010-SR-000-00-mmModel S.S.K-Files MM mark 21mm #10 6pcs/packRef D-P.02.01-031-02-015-SR-000-00-mmModel S.S.K-Files MM mark 31mm #15 6pcs/packRef D-P.02.01-031-02-008-SR-000-00-mmModel S.S.K-Files MM mark 31mm #08 6pcs/packRef D-P.04.01-025-02-006-SR-000-00-00Model S.S.K-Files MM mark 25mm #06 6pcs/packRef D-P.04.01-025-02-035-SR-000-00-00Model S.S.K-Files MM mark 25mm #35 6pcs/packRef D-P.04.01-025-02-008-SR-000-00-00Model S.S.K-Files MM mark 25mm #08 6pcs/packRef D-P.04.01-025-02-0A1-SR-000-00-00Model S.S.K-Files MM mark 25mm #45-80 6pcs/packRef D-P.04.01-025-02-045-SR-000-00-00Model S.S.K-Files MM mark 25mm #45 6psc/packRef D-P.04.01-025-02-025-SR-000-00-00Model S.S.K-Files MM mark 25mm #25 6pcs/packRef D-P.02.01-031-02-020-SR-000-00-mmModel S.S.K-Files MM mark 31mm #20 6pcs/packRef D-P.02.01-031-02-0A0-SR-000-00-mmModel S.S.K-Files MM mark 31mm #15-40 6pcs/packRef D-P.02.01-031-02-006-SR-000-00-mmModel S.S.K-Files MM mark 31mm #06 6pcs/packRef D-P.04.01-025-02-010-SR-000-00-00Model S.S.K-Files MM mark 25mm #10 6pcs/pack
Identity
- Trade Name
- S.S.K-Files MM mark EUDAMED
- Device Name
- S.S.K-Files MM mark EUDAMED
- Model / Reference
- S.S.K-Files MM mark 31mm #45-80 6pcs/pack EUDAMEDD-P.02.01-031-02-0A1-SR-000-00-mm EUDAMEDS.S.K-Files MM mark 21mm #10 6pcs/pack EUDAMEDD-P.02.01-021-02-010-SR-000-00-mm EUDAMEDS.S.K-Files MM mark 31mm #15 6pcs/pack EUDAMEDD-P.02.01-031-02-015-SR-000-00-mm EUDAMEDS.S.K-Files MM mark 31mm #08 6pcs/pack EUDAMEDD-P.02.01-031-02-008-SR-000-00-mm EUDAMEDS.S.K-Files MM mark 25mm #06 6pcs/pack EUDAMEDD-P.04.01-025-02-006-SR-000-00-00 EUDAMEDS.S.K-Files MM mark 25mm #35 6pcs/pack EUDAMEDD-P.04.01-025-02-035-SR-000-00-00 EUDAMEDS.S.K-Files MM mark 25mm #08 6pcs/pack EUDAMEDD-P.04.01-025-02-008-SR-000-00-00 EUDAMEDS.S.K-Files MM mark 25mm #45-80 6pcs/pack EUDAMEDD-P.04.01-025-02-0A1-SR-000-00-00 EUDAMEDS.S.K-Files MM mark 25mm #45 6psc/pack EUDAMEDD-P.04.01-025-02-045-SR-000-00-00 EUDAMEDS.S.K-Files MM mark 25mm #25 6pcs/pack EUDAMEDD-P.04.01-025-02-025-SR-000-00-00 EUDAMEDS.S.K-Files MM mark 31mm #20 6pcs/pack EUDAMEDD-P.02.01-031-02-020-SR-000-00-mm EUDAMEDS.S.K-Files MM mark 31mm #15-40 6pcs/pack EUDAMEDD-P.02.01-031-02-0A0-SR-000-00-mm EUDAMEDS.S.K-Files MM mark 31mm #06 6pcs/pack EUDAMEDD-P.02.01-031-02-006-SR-000-00-mm EUDAMEDS.S.K-Files MM mark 25mm #10 6pcs/pack EUDAMEDD-P.04.01-025-02-010-SR-000-00-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512501795 EUDAMED06942512500491 EUDAMED06942512500613 EUDAMED06942512500286 EUDAMED06975718059982 EUDAMED06942512500569 EUDAMED06942512500279 EUDAMED06942512500590 EUDAMED06942512500583 EUDAMED06942512500545 EUDAMED06942512501788 EUDAMED06975718059890 EUDAMED06942512500606 EUDAMED06975718059999 EUDAMED
- Basic UDI-DI
- B-06942512501795 EUDAMEDB-06942512500491 EUDAMEDB-06942512500613 EUDAMEDB-06942512500286 EUDAMEDB-06975718059982 EUDAMEDB-06942512500569 EUDAMEDB-06942512500279 EUDAMEDB-06942512500590 EUDAMEDB-06942512500583 EUDAMEDB-06942512500545 EUDAMEDB-06942512501788 EUDAMEDB-06975718059890 EUDAMEDB-06942512500606 EUDAMEDB-06975718059999 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
S.S.K-Files MM mark 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-06942512501795 | 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 (14)
- EUDAMED 713e7afb-24e4-43c0-8fe6-bde2a7648680 61 fields · synced Aug 1, 2026
- EUDAMED 77fa168e-b1fb-447b-a32e-8ee851083913 61 fields · synced May 17, 2026
- EUDAMED 95527b2a-d028-4e72-affc-bcac2115c8b6 61 fields · synced May 17, 2026
- EUDAMED 7cef2f77-0015-4e63-816d-2017e2d3ca70 61 fields · synced May 17, 2026
- EUDAMED 5cb61f0f-2457-4aa5-b44f-7cc51b9b5137 61 fields · synced May 17, 2026
- EUDAMED e58e7ded-f76b-4912-9480-5ec1c086b73e 61 fields · synced May 17, 2026
- EUDAMED 97046f81-0d7b-4815-a912-e6b937b54254 61 fields · synced May 17, 2026
- EUDAMED 7df9e56e-5919-48df-bff8-ff3a2c78832d 61 fields · synced May 17, 2026
- EUDAMED e64de48d-9e68-4dff-8d8d-cec560d9f817 61 fields · synced May 17, 2026
- EUDAMED 0a3de457-f94d-47d5-8ae3-77ee21b513d0 61 fields · synced May 18, 2026
- EUDAMED bb1ed0c6-d825-411d-9fbe-c433fadc675a 61 fields · synced May 18, 2026
- EUDAMED 760f220e-6188-4604-bd20-fdb270c408c6 61 fields · synced May 18, 2026
- EUDAMED 7336d1dd-a433-4f76-ad0e-65687995edff 61 fields · synced May 18, 2026
- EUDAMED db6d0f7e-12a5-4cc6-af7c-ef7c437dcb7e 61 fields · synced May 18, 2026