← Back to catalogue
NiTi Pro Flexi Files Chameleon
EUDAMEDClass IIa (EU MDR)
Ref CODE2821204Model E28 NiTi Pro Flexi Files Chameleon 6s 21mm No.20/04
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 21mm No.20/04 EUDAMEDCODE2821204 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512504697 EUDAMED
- Basic UDI-DI
- B-06942512504697 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-06942512504697 | 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 913ff3e7-e7c5-4b16-a294-44e03c15ffbd 61 fields · synced Jun 18, 2026