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NiTi Pro Flexi Files Chameleon
EUDAMEDClass IIa (EU MDR)
Ref CODE2825256Model E28 NiTi Pro Flexi Files Chameleon 6s 25mm No.25/06Ref CODE2825354Model E28 NiTi Pro Flexi Files Chameleon 6s 25mm No.35/04Ref CODE2821ASSTModel E28 NiTi Pro Flexi Files Chameleon 6s 21mm Asst.Ref CODE2825ASSTModel E28 NiTi Pro Flexi Files Chameleon 6s 25mm Asst.Ref CODE2821256Model E28 NiTi Pro Flexi Files Chameleon 6s 21mm No.25/06Ref CODE2825304Model E28 NiTi Pro Flexi Files Chameleon 6s 25mm No.30/04Ref CODE2821354Model E28 NiTi Pro Flexi Files Chameleon 6s 21mm No.35/04Ref CODE2819019Model E28 NiTi Pro Flexi Files Chameleon 6s 19mm No.01/09
Identity
- Trade Name
- NiTi Pro Flexi Files Chameleon EUDAMED
- Device Name
- Dental Root Canal Instruments Files EUDAMED
- Model / Reference
- E28 NiTi Pro Flexi Files Chameleon 6s 25mm No.25/06 EUDAMEDCODE2825256 EUDAMEDE28 NiTi Pro Flexi Files Chameleon 6s 25mm No.35/04 EUDAMEDCODE2825354 EUDAMEDE28 NiTi Pro Flexi Files Chameleon 6s 21mm Asst. EUDAMEDCODE2821ASST EUDAMEDE28 NiTi Pro Flexi Files Chameleon 6s 25mm Asst. EUDAMEDCODE2825ASST EUDAMEDE28 NiTi Pro Flexi Files Chameleon 6s 21mm No.25/06 EUDAMEDCODE2821256 EUDAMEDE28 NiTi Pro Flexi Files Chameleon 6s 25mm No.30/04 EUDAMEDCODE2825304 EUDAMEDE28 NiTi Pro Flexi Files Chameleon 6s 21mm No.35/04 EUDAMEDCODE2821354 EUDAMEDE28 NiTi Pro Flexi Files Chameleon 6s 19mm No.01/09 EUDAMEDCODE2819019 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512504772 EUDAMED06942512504796 EUDAMED06942512504741 EUDAMED06942512504802 EUDAMED06942512504710 EUDAMED06942512504789 EUDAMED06942512504734 EUDAMED06942512504680 EUDAMED
- Basic UDI-DI
- B-06942512504772 EUDAMEDB-06942512504796 EUDAMEDB-06942512504741 EUDAMEDB-06942512504802 EUDAMEDB-06942512504710 EUDAMEDB-06942512504789 EUDAMEDB-06942512504734 EUDAMEDB-06942512504680 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 Chameleon 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-06942512504772 | 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 (8)
- EUDAMED c1b69f98-a499-4d38-bf33-cf338a054e65 61 fields · synced Jul 24, 2026
- EUDAMED 851560da-760c-47d9-aa94-87eb5206b704 61 fields · synced May 16, 2026
- EUDAMED e6192fe0-f5a2-4ca3-ab5d-ca263e1c3f98 61 fields · synced May 18, 2026
- EUDAMED 5dfd60de-786c-492c-9ee9-4fb949a2ac8d 61 fields · synced May 18, 2026
- EUDAMED 3844f104-01ad-4669-860b-9b3a27c09788 61 fields · synced May 18, 2026
- EUDAMED 00cb970b-2725-481d-897f-f1886e7b5a85 61 fields · synced May 18, 2026
- EUDAMED ced4e4b9-cb38-4a1e-8b07-7094a96ba2a5 61 fields · synced May 18, 2026
- EUDAMED 6a01de5a-7c34-451d-885f-53cf114ebfb8 61 fields · synced May 18, 2026