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Disposable 3-in-1 Trays with Aluminium Bar Connectors
EUDAMEDClass I (EU MDR)
Ref T403Ref T401Ref T402
Identity
- Trade Name
- Disposable 3-in-1 Trays with Aluminium Bar Connectors EUDAMED
- Device Name
- Dental Impression Trays EUDAMED
- Model / Reference
- T403 EUDAMEDT401 EUDAMEDT402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125T4032 EUDAMED+D125T4012 EUDAMED+D125T4022 EUDAMED
- Basic UDI-DI
- ++D125IMPRESSIONTRAYUP EUDAMED
- Unit of Use DI
- 2 EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE 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
Category: Dental impression tray, single-use
Disposable 3-in-1 Trays with Aluminium Bar Connectors by Premium Plus (Dongguan) Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental impression tray, single-use.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D125IMPRESSIONTRAYUP | Class I | Active |
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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 (3)
- EUDAMED f0a557dc-40f8-4c62-b351-1d32e9374251 61 fields · synced Aug 1, 2026
- EUDAMED 1362959d-fcc0-4838-9c83-fa3b83414442 61 fields · synced May 17, 2026
- EUDAMED 913ec6cf-aa6f-4473-be6a-1280d3fd89ae 61 fields · synced May 17, 2026