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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 European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++D125FLUORIDETRAYEC Basic UDI-DI Date7 Apr 2025RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

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

Similar devices in this category

Other devices filed under DENTAL INSTRUMENTS, SINGLE-USE - OTHER.

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Properties

Other properties (14, all answered No)