Dental Burs
by Shenzhen Americuras Co., Ltd 312 variants
Ref TR-25Model FG1-FG-1/4、FG1-FG-1/2、FG1-FG-1、 FG1-FG-2、FG1-FG-3、FG1-FG-4、 FG1-FG-5、FG1-FG-6、FG1-FG-7、 FG1-FG-8、FG1-RA-1/2、FG1-RA-1、 FG1-RA-2、FG1-RA-3、FG1-RA-4、 FG1-RA-5、FG1-RA-6、FG1-RA-7、etc
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 | Number697820314DBYR 06978203148949 | Date26 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- Withdrawn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
- Device Name
- Dental Burs
- Model / Reference
- FG1-FG-1/4、FG1-FG-1/2、FG1-FG-1、 FG1-FG-2、FG1-FG-3、FG1-FG-4、 FG1-FG-5、FG1-FG-6、FG1-FG-7、 FG1-FG-8、FG1-RA-1/2、FG1-RA-1、 FG1-RA-2、FG1-RA-3、FG1-RA-4、 FG1-RA-5、FG1-RA-6、FG1-RA-7、etc, TR-25
- Primary DI / UDI-DI
- 06978203148949
- Basic UDI-DI
- 697820314DBYR
- EMDN Code
- Q010501 Dental burs and abrasive disks, 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