← Back to catalogue
Only One File
EUDAMEDClass IIa (EU MDR)
Ref D-P.01.04-021-06-040-RB-000-00-00Model Chameleon Series - ONLY ONE FILE 21mm #40 6pcs/pack
Identity
- Trade Name
- ONLY ONE FILE EUDAMED
- Device Name
- ONLY ONE FILE EUDAMED
- Model / Reference
- Chameleon Series - ONLY ONE FILE 21mm #40 6pcs/pack EUDAMEDD-P.01.04-021-06-040-RB-000-00-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975718054420 EUDAMED
- Basic UDI-DI
- B-06975718054420 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
Only One File 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-06975718054420 | 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 845cb40b-6803-491d-a21f-25770ff46871 61 fields · synced Jun 17, 2026