Medical plastic trays
by Huanghua Promisee Dental Co.Ltd. 12 variants
Ref APT01Model APT01,AK01, AK01 16, AK01 16a, AK01 17, AK01 18, AK01 19, AK01 20,DPT01,DPT02,DPT03,DPT04,NC01
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 | Number69544540MEPT001UF 06954454001431 | Date17 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- Withdrawn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
- Model / Reference
- APT01, AK01, AK01 16, AK01 16a, AK01 17, AK01 18, AK01 19, AK01 20, DPT01, DPT02, DPT03, DPT04, NC01
- Primary DI / UDI-DI
- 06954454001431
- Basic UDI-DI
- 69544540MEPT001UF
- 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