Barrier Film Dispenser
by Huanghua Promisee Dental Co.Ltd.
Ref TH06BModel TH02L,TH02S,TH04MFL,TH04MFS,TH04MF7,TH06A,TH06B,TH07
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 | Number69544540DAOH001K3 06954454001936 | Date18 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- Withdrawn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
- Dental Acrylic Organizer Holder
- Model / Reference
- TH02L, TH02S, TH04MFL, TH04MFS, TH04MF7, TH06A, TH06B, TH07
- Primary DI / UDI-DI
- 06954454001936
- Basic UDI-DI
- 69544540DAOH001K3
- EMDN Code
- Q0199 Odontology 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