Barbed broaches
by Shanwei Perfect Medical Instruments Co., Ltd. 40 variants
Ref F330 630 908 2800 030、F330 630 908 2800 035、F330 630 908 2800 040Model Barbed Broach
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 | Number697590932BarbedBroachZ2 | Date16 May 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- Withdrawn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 Root-Canal Instruments
- Model / Reference
- Barbed Broach, F330 630 908 2800 030、F330 630 908 2800 035、F330 630 908 2800 040
- Primary DI / UDI-DI
- 06942200970612, 06942200970629
- Basic UDI-DI
- 697590932BarbedBroachZ2
- EMDN Code
- Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000033003
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shanwei Perfect Medical Instruments Co., Ltd.
See all devices from Shanwei Perfect 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