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Super Files II
EUDAMEDClass IIa (EU MDR)
Ref D-P.01.02-031-06-PX4-RB-000-00-00Model Chameleon Series -Super Files II 31mm X4 6pcs/pack
Identity
- Trade Name
- Super Files II EUDAMED
- Device Name
- Super Files II EUDAMED
- Model / Reference
- Chameleon Series -Super Files II 31mm X4 6pcs/pack EUDAMEDD-P.01.02-031-06-PX4-RB-000-00-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975718052846 EUDAMED
- Basic UDI-DI
- B-06975718052846 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Super Files II 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-06975718052846 | 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 5d8a9c5b-4a80-4a78-8278-1017fd66d642 61 fields · synced Jun 18, 2026