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Disposable 3-in-1 Trays
EUDAMEDClass I (EU MDR)
Ref 18-N402Ref 18-N404Ref 18-N403Ref N404Ref 18-N401
Identity
- Trade Name
- Disposable 3-in-1 Trays EUDAMED
- Device Name
- Dental Impression Trays EUDAMED
- Model / Reference
- 18-N402 EUDAMED18-N404 EUDAMED18-N403 EUDAMEDN404 EUDAMED18-N401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D12518N4022 EUDAMED+D12518N4042 EUDAMED+D12518N4032 EUDAMED+D125N4042 EUDAMED+D12518N4012 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 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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- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- Zap Dual Arch Flouride Gel Trays — CROSSTEX INTERNATIONAL, INC. · Class I
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 (5)
- EUDAMED b55e776f-a5ab-4e63-8d92-ff658c99a901 61 fields · synced Oct 6, 2026
- EUDAMED ea91a8ce-1ead-475b-958f-9b5df8c77ee7 61 fields · synced May 17, 2026
- EUDAMED bed51511-31af-4eb3-ad81-ac7e894e4fd9 61 fields · synced May 17, 2026
- EUDAMED 39b3c5e2-bbdd-41da-9028-24ebf4706e97 61 fields · synced May 17, 2026
- EUDAMED 8ffc3c0a-2333-48ce-805d-f545625566e2 61 fields · synced May 19, 2026