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NiTi One Files Blue
EUDAMEDClass IIa (EU MDR)
Ref CODE0525R25Model E05 NiTi One Files Blue 6s 25mm No.R25Ref CODE0521R25Model E05 NiTi One Files Blue 6s 21mm No.R25Ref CODE0531R25Model E05 NiTi One Files Blue 6s 31mm No.R25Ref CODE0521R40Model E05 NiTi One Files Blue 6s 21mm No.R40Ref CODE0521ASSTModel E05 NiTi One Files Blue 6s 21mm Asst.Ref CODE0525R40Model E05 NiTi One Files Blue 6s 25mm No.R40Ref CODE0521R50Model E05 NiTi One Files Blue 6s 21mm No.R50
Identity
- Trade Name
- NiTi One Files Blue EUDAMED
- Device Name
- Dental Root Canal Instruments Files EUDAMED
- Model / Reference
- E05 NiTi One Files Blue 6s 25mm No.R25 EUDAMEDCODE0525R25 EUDAMEDE05 NiTi One Files Blue 6s 21mm No.R25 EUDAMEDCODE0521R25 EUDAMEDE05 NiTi One Files Blue 6s 31mm No.R25 EUDAMEDCODE0531R25 EUDAMEDE05 NiTi One Files Blue 6s 21mm No.R40 EUDAMEDCODE0521R40 EUDAMEDE05 NiTi One Files Blue 6s 21mm Asst. EUDAMEDCODE0521ASST EUDAMEDE05 NiTi One Files Blue 6s 25mm No.R40 EUDAMEDCODE0525R40 EUDAMEDE05 NiTi One Files Blue 6s 21mm No.R50 EUDAMEDCODE0521R50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512503294 EUDAMED06942512503256 EUDAMED06942512503331 EUDAMED06942512503263 EUDAMED06942512503249 EUDAMED06942512503300 EUDAMED06942512503270 EUDAMED
- Basic UDI-DI
- B-06942512503294 EUDAMEDB-06942512503256 EUDAMEDB-06942512503331 EUDAMEDB-06942512503263 EUDAMEDB-06942512503249 EUDAMEDB-06942512503300 EUDAMEDB-06942512503270 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 Blue 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-06942512503294 | 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 (7)
- EUDAMED 09d9f98c-73e2-4897-acf7-0164c690b1ff 61 fields · synced Aug 1, 2026
- EUDAMED da013ba9-a85f-4b6b-a8d5-fa87cb9621c1 61 fields · synced May 16, 2026
- EUDAMED e6846668-25d2-4fb8-8e44-183cf5b487ab 61 fields · synced May 17, 2026
- EUDAMED 0aa39b46-38e9-44af-afcd-e3d9e5d3825c 61 fields · synced May 17, 2026
- EUDAMED 0a93d61b-4d38-4590-a63e-9285aa608d86 61 fields · synced May 18, 2026
- EUDAMED fdf3ba8b-83e2-4e85-98ba-1b6166bf3a77 61 fields · synced May 19, 2026
- EUDAMED 634ee7e9-7926-4e53-9b96-a27681c4c3aa 61 fields · synced May 19, 2026