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Only One File
EUDAMEDClass IIa (EU MDR)
Ref D-P.01.04-031-06-040-RB-000-00-00Model Chameleon Series - ONLY ONE FILE 31mm #40 6pcs/packRef D-P.01.04-021-VT-0A0-RB-000-00-00Model Chameleon Series - ONLY ONE FILE 21mm #25-#50 6pcs/packRef D-P.01.04-021-08-025-RB-000-00-00Model Chameleon Series - ONLY ONE FILE 21mm #25 6pcs/packRef D-P.01.04-025-VT-0A1-RB-000-00-00Model Chameleon Series - ONLY ONE FILE 25mm #25-#35 6pcs/packRef D-P.01.04-031-VT-0A1-RB-000-00-00Model Chameleon Series - ONLY ONE FILE 31mm #25-#35 6pcs/packRef D-P.01.04-031-08-025-RB-000-00-00Model Chameleon Series - ONLY ONE FILE 31mm #25 6pcs/packRef D-P.01.04-021-04-035-RB-000-00-00Model Chameleon Series - ONLY ONE FILE 21mm #35 6pcs/packRef D-P.01.04-031-05-050-RB-000-00-00Model Chameleon Series - ONLY ONE FILE 31mm #50 6pcs/packRef D-P.01.04-031-04-030-RB-000-00-00Model Chameleon Series - ONLY ONE FILE 31mm #30 6pcs/packRef D-P.01.04-025-06-040-SR-000-00-00Model Only One Files 25mm R40 6pcs/pack
Identity
- Trade Name
- ONLY ONE FILE EUDAMED
- Device Name
- ONLY ONE FILE EUDAMEDOnly One Files EUDAMED
- Model / Reference
- Chameleon Series - ONLY ONE FILE 31mm #40 6pcs/pack EUDAMEDD-P.01.04-031-06-040-RB-000-00-00 EUDAMEDChameleon Series - ONLY ONE FILE 21mm #25-#50 6pcs/pack EUDAMEDD-P.01.04-021-VT-0A0-RB-000-00-00 EUDAMEDChameleon Series - ONLY ONE FILE 21mm #25 6pcs/pack EUDAMEDD-P.01.04-021-08-025-RB-000-00-00 EUDAMEDChameleon Series - ONLY ONE FILE 25mm #25-#35 6pcs/pack EUDAMEDD-P.01.04-025-VT-0A1-RB-000-00-00 EUDAMEDChameleon Series - ONLY ONE FILE 31mm #25-#35 6pcs/pack EUDAMEDD-P.01.04-031-VT-0A1-RB-000-00-00 EUDAMEDChameleon Series - ONLY ONE FILE 31mm #25 6pcs/pack EUDAMEDD-P.01.04-031-08-025-RB-000-00-00 EUDAMEDChameleon Series - ONLY ONE FILE 21mm #35 6pcs/pack EUDAMEDD-P.01.04-021-04-035-RB-000-00-00 EUDAMEDChameleon Series - ONLY ONE FILE 31mm #50 6pcs/pack EUDAMEDD-P.01.04-031-05-050-RB-000-00-00 EUDAMEDChameleon Series - ONLY ONE FILE 31mm #30 6pcs/pack EUDAMEDD-P.01.04-031-04-030-RB-000-00-00 EUDAMEDOnly One Files 25mm R40 6pcs/pack EUDAMEDD-P.01.04-025-06-040-SR-000-00-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975718054567 EUDAMED06975718054451 EUDAMED06975718054390 EUDAMED06975718054512 EUDAMED06975718054581 EUDAMED06975718054536 EUDAMED06975718054413 EUDAMED06975718054574 EUDAMED06975718054543 EUDAMED06970514912073 EUDAMED
- Basic UDI-DI
- B-06975718054567 EUDAMEDB-06975718054451 EUDAMEDB-06975718054390 EUDAMEDB-06975718054512 EUDAMEDB-06975718054581 EUDAMEDB-06975718054536 EUDAMEDB-06975718054413 EUDAMEDB-06975718054574 EUDAMEDB-06975718054543 EUDAMEDB-06970514912073 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-06975718054567 | 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 (10)
- EUDAMED b2b27ce0-5a3b-4ea9-8c6b-55423e9a2c7d 61 fields · synced Sep 18, 2026
- EUDAMED a9d7a5f5-3ed5-48df-be5e-f076b95fd307 61 fields · synced May 17, 2026
- EUDAMED 208aa5bf-76b6-46b8-acb5-79673ec6d09b 61 fields · synced May 17, 2026
- EUDAMED 10b69227-956e-4b0a-89e5-cce589ab8ca8 61 fields · synced May 17, 2026
- EUDAMED 62542523-a8fe-4c05-b95c-76d3576600d3 61 fields · synced May 18, 2026
- EUDAMED f8ee66c5-b062-4ebc-b741-1212cfb8d6b2 61 fields · synced May 18, 2026
- EUDAMED 85f6c27d-862b-4caf-b72a-a308f44b5339 61 fields · synced May 19, 2026
- EUDAMED 9ace5641-ff78-444c-85d4-3d3a86e87525 61 fields · synced May 19, 2026
- EUDAMED d08d9159-bdff-440d-b412-1aca48851a6d 61 fields · synced May 19, 2026
- EUDAMED a03c462e-5ccb-488d-85ff-edafb7f8852e 61 fields · synced May 19, 2026