Identity
- Trade Name
- TC EUDAMED
- Device Name
- Rotary Files EUDAMED
- Model / Reference
- 06973058644080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973058644080 EUDAMED
- Basic UDI-DI
- 697305864RF38 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
Tc 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 | 697305864RF38 | 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 d30e7fa5-3995-452d-b5e7-7830a96f75f9 61 fields · synced Jul 14, 2026