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NiTi Dual Shaper Files Chameleon
EUDAMEDClass IIa (EU MDR)
Ref CODE1819SXModel E18 NiTi Dual Shaper Files Chameleon 5s 19mm No.SX
Identity
- Trade Name
- NiTi Dual Shaper Files Chameleon EUDAMED
- Device Name
- Dental Root Canal Instruments Files EUDAMED
- Model / Reference
- E18 NiTi Dual Shaper Files Chameleon 5s 19mm No.SX EUDAMEDCODE1819SX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512504482 EUDAMED
- Basic UDI-DI
- B-06942512504482 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 Dual Shaper 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-06942512504482 | 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 (1)
- EUDAMED f377102c-7ad5-4d7d-9c80-ca094a18f40f 61 fields · synced Jun 17, 2026