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NiTi Pro Flexi Files Blue
EUDAMEDClass IIa (EU MDR)
Ref CODE0325304Model E03 NiTi Pro Flexi Files Blue 6s 25mm No.30/04Ref CODE0325254Model E03 NiTi Pro Flexi Files Blue 6s 25mm No.25/04Ref CODE0321256Model E03 NiTi Pro Flexi Files Blue 6s 21mm No.25/06Ref CODE0321ASSTModel E03 NiTi Pro Flexi Files Blue 6s 21mm Asst.Ref CODE0321354Model E03 NiTi Pro Flexi Files Blue 6s 21mm No.35/04
Identity
- Trade Name
- NiTi Pro Flexi Files Blue EUDAMED
- Device Name
- Dental Root Canal Instruments Files EUDAMED
- Model / Reference
- E03 NiTi Pro Flexi Files Blue 6s 25mm No.30/04 EUDAMEDCODE0325304 EUDAMEDE03 NiTi Pro Flexi Files Blue 6s 25mm No.25/04 EUDAMEDCODE0325254 EUDAMEDE03 NiTi Pro Flexi Files Blue 6s 21mm No.25/06 EUDAMEDCODE0321256 EUDAMEDE03 NiTi Pro Flexi Files Blue 6s 21mm Asst. EUDAMEDCODE0321ASST EUDAMEDE03 NiTi Pro Flexi Files Blue 6s 21mm No.35/04 EUDAMEDCODE0321354 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512503157 EUDAMED06942512503133 EUDAMED06942512503089 EUDAMED06942512503119 EUDAMED06942512503102 EUDAMED
- Basic UDI-DI
- B-06942512503157 EUDAMEDB-06942512503133 EUDAMEDB-06942512503089 EUDAMEDB-06942512503119 EUDAMEDB-06942512503102 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 Pro Flexi 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-06942512503157 | 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 (5)
- EUDAMED 34fa3fdb-c3cb-48d5-b71e-f69ad679f161 61 fields · synced Aug 2, 2026
- EUDAMED 74285f0e-8e39-44f1-964e-129f8152b1a8 61 fields · synced May 18, 2026
- EUDAMED 1cf15ad0-ee43-455c-99f8-2f4dfa977685 61 fields · synced May 18, 2026
- EUDAMED 9da31ab4-7152-42ef-ae88-864abfbabd88 61 fields · synced May 18, 2026
- EUDAMED 29cc0d5a-da84-4ad1-a4ae-0d0dc888bff0 61 fields · synced May 18, 2026