← Back to catalogue
NiTi One Files Silver
EUDAMEDClass IIa (EU MDR)
Ref CODE062550Model E06 NiTi One Files Silver 6s 25mm No. R50Ref CODE063150Model E06 NiTi One Files Silver 6s 31mm No. R50Ref CODE062540Model E06 NiTi One Files Silver 6s 25mm No. R40Ref CODE0625ASSTModel E06 NiTi One Files Silver 6s 25mm Asst.Ref CODE063140Model E06 NiTi One Files Silver 6s 31mm No. R40Ref CODE062150Model E06 NiTi One Files Silver 6s 21mm No. R50
Identity
- Trade Name
- NiTi One Files Silver EUDAMED
- Device Name
- Dental Root Canal Instruments Files EUDAMED
- Model / Reference
- E06 NiTi One Files Silver 6s 25mm No. R50 EUDAMEDCODE062550 EUDAMEDE06 NiTi One Files Silver 6s 31mm No. R50 EUDAMEDCODE063150 EUDAMEDE06 NiTi One Files Silver 6s 25mm No. R40 EUDAMEDCODE062540 EUDAMEDE06 NiTi One Files Silver 6s 25mm Asst. EUDAMEDCODE0625ASST EUDAMEDE06 NiTi One Files Silver 6s 31mm No. R40 EUDAMEDCODE063140 EUDAMEDE06 NiTi One Files Silver 6s 21mm No. R50 EUDAMEDCODE062150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512503522 EUDAMED06942512503560 EUDAMED06942512503515 EUDAMED06942512503539 EUDAMED06942512503553 EUDAMED06942512503485 EUDAMED
- Basic UDI-DI
- B-06942512503522 EUDAMEDB-06942512503560 EUDAMEDB-06942512503515 EUDAMEDB-06942512503539 EUDAMEDB-06942512503553 EUDAMEDB-06942512503485 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 One Files Silver 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-06942512503522 | 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 (6)
- EUDAMED 486ebe8a-3584-49be-90be-772b97272074 61 fields · synced Jul 30, 2026
- EUDAMED 94fe48d3-4166-47de-8cba-4196ca7d8028 61 fields · synced May 11, 2026
- EUDAMED d1a1f481-943e-43f0-8423-abbd11e5f634 61 fields · synced May 17, 2026
- EUDAMED e485b234-e8ca-4849-b542-6b59c88e601c 61 fields · synced May 17, 2026
- EUDAMED e8ecdb21-9731-4a16-952b-08b71952f82f 61 fields · synced May 17, 2026
- EUDAMED bb7d6165-9080-4b53-86f4-7bae16bd05e3 61 fields · synced May 18, 2026