Dental Root Canal File
by Jining Orodeka Medical Equipment CO; LTD China EUDAMED
Ref Engine Use H-file025/07 19mm Engine Use H-file025/07 19mm Engine Use H-file020/06 21mm Engine Use H-file020/06 21mmModel Engine Use H-file EMDN Q010507
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697284234EngineusehfileEH | Date15 Jul 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- Withdrawn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 H-file, Engine Use H-file025/07 19mm Engine Use H-file025/07 19mm Engine Use H-file020/06 21mm Engine Use H-file020/06 21mm
- Primary DI / UDI-DI
- 06972842349651
- Basic UDI-DI
- 697284234EngineusehfileEH
- 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
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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 06972842349651|697284234ENGINEUSEHFILEEH