Silicone Small Bowl
by Huanghua Promisee Dental Co.Ltd. 5 variants
Ref SB01SModel MB01,MB02,MB03,MB04,DD01,DD02,DD030A,DD030B,SB01XL,SB01L,SB01M, SB01S,SB01SS,MW03,MW01,MW02,GD01
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 | Number69544540MIBO001Q6 06954454000687 | Date11 Mar 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- Withdrawn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
- Mixing Bowl
- Model / Reference
- MB01, MB02, MB03, MB04, DD01, DD02, DD030A, DD030B, SB01XL, SB01L, SB01M, SB01S, SB01SS, MW03, MW01, MW02, GD01
- Primary DI / UDI-DI
- 06954454000687
- Basic UDI-DI
- 69544540MIBO001Q6
- EMDN Code
- Q010299 Prosthetic dentistry devices - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000014766
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Huanghua Promisee Dental 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