Orthodontic Impression Trays

by Ortho-Care (UK) Limited 7 variants

Ref 150-305Model Orthodontic Impression Trays

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number50563346IMPRESSIONSUIJW Basic UDI-DI 05056334600305UDI-DI	Date29 Nov 2022Registered	StatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Orthodontic Impression Trays
Model / Reference: Orthodontic Impression Trays, 150-305

Primary DI / UDI-DI: 05056334600305
Basic UDI-DI: 50563346IMPRESSIONSUIJW
EMDN Code: Q010503 Impression material trays, single-use

Device Class: Class I
EU market of registration: Northern Ireland

Manufacturer details

EUDAMED SRN: GB-MF-000010884
Authorised representative: Advena Limited MT-AR-000000234

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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