Identity
- Trade Name
- K-Files EUDAMED
- Device Name
- Manual Files EUDAMED
- Model / Reference
- 697305864MF2R EUDAMED6973058641362 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973058641362 EUDAMED
- Basic UDI-DI
- 697305864MF2R EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
K-Files by Huizhou Videya Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697305864MF2R | Class IIa | Active |
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Manufacturer
- Manufacturer
- Huizhou Videya Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000029830
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 0a507f32-9021-4b6d-af84-3cd2eeadce4d 61 fields · synced Jul 25, 2026