Dental Trays
by Premium Plus (Dongguan) Limited
Ref CS-02420, CS-02421
Dental Trays (CS-02420) is a Class I device made by Premium Plus (Dongguan) Limited, registered in EUDAMED on 7 Apr 2025 (Basic UDI-DI ++D125FLUORIDETRAYEC), active as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++D125FLUORIDETRAYEC | Date7 Apr 2025 | StatusActive |
Official records
- EUDAMED public site ++D125FLUORIDETRAYEC
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- Withdrawn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
- Fluoride Trays
- Model / reference
- CS-02420, CS-02421
- Primary DI / UDI-DI
- +D125ITDTCS024202, +D125ITDTCS024212
- Basic UDI-DI
- ++D125FLUORIDETRAYEC
- Unit of use DI
- 2
- EMDN code
- Q010599 Dental instruments, single-use - other
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000038259
- Authorised representative
- Premium Plus Poland sp. z o.o. PL-AR-000030110
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