Applicator Tip
by Huanghua Promisee Dental Co.Ltd. 3 variants
Ref /Model BA01,ECOBA01A,ECOBA01B,AT01,AT01L,AT01S,ECOAT01B,BH01,ECOBH01B,DH01,DH02
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 | Number69544540GIBR001MM 06954454002483 | Date4 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- Withdrawn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
- Gingival Brushes
- Model / Reference
- BA01, ECOBA01A, ECOBA01B, AT01, AT01L, AT01S, ECOAT01B, BH01, ECOBH01B, DH01, DH02, /
- Primary DI / UDI-DI
- 06954454002483
- Basic UDI-DI
- 69544540GIBR001MM
- EMDN Code
- Q019006 Dental material application tips and brushes, single-use
- Device Class
- Class I
- EU market of registration
- Germany
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 (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No