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Supratray Impression Trays Quadrant
EUDAMEDClass I (EU MDR)
Ref 3180111Ref 3180108
Identity
- Trade Name
- Supratray Impression Trays Quadrant EUDAMED
- Device Name
- Dental Impression Trays EUDAMED
- Model / Reference
- 3180111 EUDAMED3180108 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125JD31801112 EUDAMED+D125JD31801082 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
Supratray Impression Trays Quadrant 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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- 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 (2)
- EUDAMED 07bd03b3-a848-4b1e-804c-386cdc108823 61 fields · synced Oct 6, 2026
- EUDAMED 6a16ece0-9901-48c2-a22f-a3437486aff0 61 fields · synced May 18, 2026