Identity
- Trade Name
- Cheek Retractors EUDAMED
- Device Name
- Mouth Retractors EUDAMED
- Model / Reference
- 2050A EUDAMED2055A EUDAMED2055C EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D1252050A2 EUDAMED+D1252055A2 EUDAMED+D1252055C2 EUDAMED
- Basic UDI-DI
- ++D125MOUTHRETRACTOR67 EUDAMED
- Unit of Use DI
- 2 EUDAMED
- EMDN Code
- L150201 DENTAL RETRACTORS, REUSABLE 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
Cheek Retractors by Premium Plus (Dongguan) Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | ++D125MOUTHRETRACTOR67 | 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 39ece6e2-6e7b-4025-8424-c5b7433e6757 61 fields · synced Jul 21, 2026
- EUDAMED 2de17329-694b-4741-8385-d4210e955033 61 fields · synced May 17, 2026
- EUDAMED accd736c-8970-4199-b904-16c69d3c59b0 61 fields · synced May 17, 2026