Disposable Impression Trays

by Premium Plus (Dongguan) Limited China EUDAMED

Ref 415

EMDN Q010503

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number++D125IMPRESSIONTRAYUP Basic UDI-DI	Date14 Jul 2025Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name: Dental Impression Trays
Model / Reference: 415

Primary DI / UDI-DI: +D125FRRM4154
Basic UDI-DI: ++D125IMPRESSIONTRAYUP
EMDN Code: Q010503 Impression material trays, single-use

Device Class: Class I
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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Properties & raw data

Show properties, registry sources and raw records

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

Sources (1)

EUDAMED f9a42364-0a23-436a-b55c-cf66980cd544 61 fields · synced 22 Oct 2026