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Only One Files
EUDAMEDClass IIa (EU MDR)
Ref D-P.01.04-031-08-025-SR-000-00-00Model Only One Files 31mm R25 6pcs/pack
Identity
- Trade Name
- Only One Files EUDAMED
- Device Name
- Only One Files EUDAMED
- Model / Reference
- Only One Files 31mm R25 6pcs/pack EUDAMEDD-P.01.04-031-08-025-SR-000-00-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970514912097 EUDAMED
- Basic UDI-DI
- B-06970514912097 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 Files 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-06970514912097 | 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 939a3cfb-bf7c-47c5-8b16-369748e6107f 61 fields · synced Jun 18, 2026