Dental Diaphragms
by Besumi Medical Technology(Shanghai)Co., Ltd 7 variants
Ref BSM-FA-C075Model BSM-FA-C050,BSM-FA-C075,BSM-FA-C080, BSM-FA-C100,BSM-FA-C120,BSM-FA-C150,BSM-FA-C180, BSM-FA-C200,BSM-FA-S100,BSM-FA-S150,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 | Number697980626DiaphragmsGG 06979806260014 | Date4 Feb 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- Withdrawn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 Diaphragms
- Model / Reference
- BSM-FA-C050, BSM-FA-C075, BSM-FA-C080, BSM-FA-C100, BSM-FA-C120, BSM-FA-C150, BSM-FA-C180, BSM-FA-C200, BSM-FA-S100, BSM-FA-S150, etc.
- Primary DI / UDI-DI
- 06979806260014
- Basic UDI-DI
- 697980626DiaphragmsGG
- EMDN Code
- Q010699 Materials for the preparation of custom-made dental devices - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000051650
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Besumi Medical Technology(Shanghai)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