Root Canal Files
by Shenzhen Americuras Co., Ltd 863 variants
Ref HNREM080225Model HSHFI060221
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
The Root Canal Files device is a standard medical device used in the treatment of root canals. It features a unique design and a clear understanding of its purpose, making it an excellent choice for dental professionals. The device has undergone thorough testing to ensure its safety and effectiveness.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697908165DRCFRV 06979081654508 | Date21 Jan 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- HSHFI060221, HNREM080225
- Primary DI / UDI-DI
- 06979081654508
- Basic UDI-DI
- 697908165DRCFRV
- EMDN Code
- Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
- Device Class
- Class I
- EU 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
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