Root Canal Files
by Shenzhen Americuras Co., Ltd China EUDAMED
Ref HSREMAS0225Model HSHFI060221
EMDN Q010507
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697908165DRCFRV | Date21 Jan 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Root Canal Files
- Model / Reference
- HSHFI060221, HSREMAS0225
- Primary DI / UDI-DI
- 06979081654423
- Basic UDI-DI
- 697908165DRCFRV
- EMDN Code
- Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000048352
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shenzhen Americuras 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 e2334b33-c442-44d0-b186-834a2dc6b1fb