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Autoclavable Impression Trays

EUDAMED

Class I (EU MDR)

Ref 439Ref 430Ref 437Ref 440Ref 435

by Premium Plus (Dongguan) Limited

Identity

Trade Name
Autoclavable Impression Trays EUDAMED
Device Name
Dental Impression Trays EUDAMED
Model / Reference
439 EUDAMED
430 EUDAMED
437 EUDAMED
440 EUDAMED
435 EUDAMED

Identifiers

Primary DI / UDI-DI
+D1254394 EUDAMED
+D1254304 EUDAMED
+D1254374 EUDAMED
+D1254404 EUDAMED
+D1254354 EUDAMED
Basic UDI-DI
++D125IMPRESSIONTRAYUP EUDAMED
Unit of Use DI
4 EUDAMED
EMDN Code
Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Poland EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Autoclavable Impression Trays by Premium Plus (Dongguan) Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Premium Plus (Dongguan) Limited
EUDAMED SRN
CN-MF-000038259
Authorised Representative
Premium Plus Poland sp. z o.o. PL-AR-000030110

Sources (5)

  • EUDAMED 34156516-1ebc-4f2b-b6e5-8f59dfa9b851 61 fields · synced Jul 28, 2026
  • EUDAMED 501e953e-c628-467c-ad1e-fd343a3aae97 61 fields · synced May 16, 2026
  • EUDAMED 5c89fd1e-b8cc-4d47-8a5c-bea21c10a485 61 fields · synced May 17, 2026
  • EUDAMED 6888c1e7-4e64-4368-bdb4-432765146753 61 fields · synced May 17, 2026
  • EUDAMED 329c6b04-cad0-494d-9b64-9fdf20047467 61 fields · synced May 18, 2026