Endo Files
by Guangzhou Befull Medical Instruments Co., Ltd 87 variants
Ref Reamers：SXModel K-Files; H-Files; Reamers; Pesso reamers; Gate drills; Barbed broaches; Paste carriers
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697825655EDFVE 06978256550614 | Date10 Nov 2025 | 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- Withdrawn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
- Device Name
- Endo Files
- Model / Reference
- K-Files, H-Files, Reamers, Pesso reamers, Gate drills, Barbed broaches, Paste carriers, Reamers：SX
- Primary DI / UDI-DI
- 06978256550614
- Basic UDI-DI
- 697825655EDFVE
- EMDN Code
- L159019 Dental finishing rasps and files, reusable
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000050099
- Authorised representative
- HyperCert Limited B.V. NL-AR-000047746
Other devices from Guangzhou Befull Medical Instruments Co., Ltd
See all devices from Guangzhou Befull Medical Instruments 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