Identity
- Trade Name
- C-Root File EUDAMED
- Device Name
- C-Root File EUDAMED
- Model / Reference
- 015/10 19mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972902588174 EUDAMED
- Basic UDI-DI
- 69729025804XG EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
C-Root File by Beijing C-Root Dental Medical Devices 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 | 69729025804XG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beijing C-Root Dental Medical Devices Co., LTD.
- EUDAMED SRN
- CN-MF-000033502
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 7715875b-7582-47ff-b6fb-887701fcbe87 61 fields · synced Aug 1, 2026