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NITI K-Files
EUDAMEDClass IIa (EU MDR)
Ref D-P.03.01-028-02-030-SR-000-00-00Model NITI K-Files 28mm #30 6pcs/packk
Identity
- Trade Name
- NITI K-Files EUDAMED
- Device Name
- NITI K-Files EUDAMED
- Model / Reference
- NITI K-Files 28mm #30 6pcs/packk EUDAMEDD-P.03.01-028-02-030-SR-000-00-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970514910437 EUDAMED
- Basic UDI-DI
- B-06970514910437 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
NITI K-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-06970514910437 | 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 (1)
- EUDAMED b12803f0-e4be-466a-b2d9-99c9c99cc0d2 61 fields · synced Jun 19, 2026