Dental Root Canal File
by Jining Orodeka Medical Equipment CO; LTD China EUDAMED
Ref Engine Use R-file015/08 19mm Engine Use R-file015/03 21mm Engine Use R-file020/05 21mm Engine Use R-file025/06 21mmModel Engine Use R-file EMDN Q010507
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697284234EngineuserfileHX | Date4 Jun 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Dental Root Canal File
- Model / Reference
- Engine Use R-file, Engine Use R-file015/08 19mm Engine Use R-file015/03 21mm Engine Use R-file020/05 21mm Engine Use R-file025/06 21mm
- Primary DI / UDI-DI
- 06972842341624
- Basic UDI-DI
- 697284234EngineuserfileHX
- EMDN Code
- Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
- Device Class
- Class IIa
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000034133
- Authorised representative
- ORODEKA S.R.L. IT-AR-000028475
Other devices from Jining Orodeka Medical Equipment CO; LTD
See all devices from Jining Orodeka Medical Equipment CO; LTD →
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED a448c157-09e6-415d-83f3-2ff8d8d9706a