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Root Canal Files
EUDAMEDClass I (EU MDR)
Ref K-Files：6#Model K-Files：6#、8#、10#、15#、20#、25#、30#、35#、40#、15～40#、45#、50#、55#、60#、70#、80#、45～80#； etc
Identity
- Device Name
- Root Canal Files EUDAMED
- Model / Reference
- K-Files：6#、8#、10#、15#、20#、25#、30#、35#、40#、15～40#、45#、50#、55#、60#、70#、80#、45～80#； etc EUDAMEDK-Files：6# EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977290910026 EUDAMED
- Basic UDI-DI
- 697729091Rootcanalfiles84 EUDAMED
- EMDN Code
- Q01010299 ROOT CANAL FILLING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Root Canal Files by Foshan Qiyang Medical Equipment Limited — Class I — 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 | 697729091Rootcanalfiles84 | Class I | Active |
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Manufacturer
- Manufacturer
- Foshan Qiyang Medical Equipment Limited
- EUDAMED SRN
- CN-MF-000040233
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED cc8bf3ff-f51e-488f-a367-a5b196a0d5ad 61 fields · synced Oct 6, 2026