← Back to catalogue
NiTi K Files
EUDAMEDClass IIa (EU MDR)
Ref CODE32K21NT45Model E32 NiTi K Files 6s 21mm No.45
Identity
- Trade Name
- NiTi K Files EUDAMED
- Device Name
- Dental Root Canal Instruments Files EUDAMED
- Model / Reference
- E32 NiTi K Files 6s 21mm No.45 EUDAMEDCODE32K21NT45 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512505236 EUDAMED
- Basic UDI-DI
- B-06942512505236 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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-06942512505236 | 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 (1)
- EUDAMED 5c1eee5b-6cef-449b-ba72-0fa3e862865d 61 fields · synced Jun 19, 2026