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Disposable Pliable Impression Trays
EUDAMEDClass I (EU MDR)
Ref 460Ref 459Ref 451Ref 453Ref 458
Identity
- Trade Name
- Disposable Pliable Impression Trays EUDAMED
- Device Name
- Dental Impression Trays EUDAMED
- Model / Reference
- 460 EUDAMED459 EUDAMED451 EUDAMED453 EUDAMED458 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D1254604 EUDAMED+D1254594 EUDAMED+D1254514 EUDAMED+D1254534 EUDAMED+D1254584 EUDAMED
- Basic UDI-DI
- ++D125IMPRESSIONTRAYUP 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 Pliable Impression 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
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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 (5)
- EUDAMED 5a51782d-dcf9-41d5-9ef2-e8b3d998eec7 61 fields · synced Jul 16, 2026
- EUDAMED 4308e735-f0e6-41cb-acd9-a8baf7cf1671 61 fields · synced May 17, 2026
- EUDAMED a3a0b95f-ac9a-4cd9-93e9-bcf346db6ecf 61 fields · synced May 18, 2026
- EUDAMED 0918b313-619c-4a1f-8212-90bf177791a5 61 fields · synced May 18, 2026
- EUDAMED 4d82a445-48e7-44f8-b845-0ed4e99e03bc 61 fields · synced May 18, 2026