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Disposable Impression Trays
EUDAMEDClass I (EU MDR)
Ref 412Ref 413Ref 418Ref 416Ref 417Ref 419Ref 415Ref 414
Identity
- Trade Name
- Disposable Impression Trays EUDAMED
- Device Name
- Dental Impression Trays EUDAMED
- Model / Reference
- 412 EUDAMED413 EUDAMED418 EUDAMED416 EUDAMED417 EUDAMED419 EUDAMED415 EUDAMED414 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D1254124 EUDAMED+D1254134 EUDAMED+D1254184 EUDAMED+D1254164 EUDAMED+D1254174 EUDAMED+D1254194 EUDAMED+D125FRRM4124 EUDAMED+D125FRRM4164 EUDAMED+D125FRRM4154 EUDAMED+D125FRRM4144 EUDAMED
- Basic UDI-DI
- ++D125IMPRESSIONTRAYUP EUDAMED
- Unit of Use DI
- 4 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 Impression Trays by Premium Plus (Dongguan) Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental impression tray, single-use.
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- IMPRESSION TRAYS PERFORATED FULL DENTURE UPPER XL U4 — Daddy D Pro · Class I
- Ador-Löffelplatten — dent a pharm Produktionsgesellschaft mbH · Class I
- 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 (10)
- EUDAMED 82d49fb0-9375-406a-ba69-819661e4aac7 61 fields · synced Aug 2, 2026
- EUDAMED 121d6a3d-8ea8-4a25-a13c-a5fa2dd38c4b 61 fields · synced May 11, 2026
- EUDAMED b13ec594-3054-43d6-9dd8-c8f5bb9a4ecf 61 fields · synced May 17, 2026
- EUDAMED 647e00d5-3e26-4f51-bb9a-ccc8e410c256 61 fields · synced May 17, 2026
- EUDAMED c1331665-9a00-4a3a-ae73-9d0466aeec2b 61 fields · synced May 18, 2026
- EUDAMED 11cd9032-17b5-4e6d-9e0e-750dd51be777 61 fields · synced May 18, 2026
- EUDAMED e4b1b350-1029-4d8c-877e-12a1c9ff9dc1 61 fields · synced Jul 9, 2026
- EUDAMED e5bb1931-1298-4292-8a34-1bcfe5717b83 61 fields · synced Jul 14, 2026
- EUDAMED f9a42364-0a23-436a-b55c-cf66980cd544 61 fields · synced Jul 28, 2026
- EUDAMED 73acc3e5-24a6-4fdb-a0cb-73d8d8f8d620 61 fields · synced Jul 30, 2026