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Intraoral Cheek Retractors
EUDAMEDClass I (EU MDR)
Ref 2060ARef 2060CRef 2080BRef 2080ARef 2080C
Identity
- Trade Name
- Intraoral Cheek Retractors EUDAMED
- Device Name
- Mouth Retractors EUDAMED
- Model / Reference
- 2060A EUDAMED2060C EUDAMED2080B EUDAMED2080A EUDAMED2080C EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D1252060A2 EUDAMED+D1252060C2 EUDAMED+D1252080B2 EUDAMED+D1252080A2 EUDAMED+D1252080C2 EUDAMED
- Basic UDI-DI
- ++D125MOUTHRETRACTOR67 EUDAMED
- Unit of Use DI
- 2 EUDAMED
- EMDN Code
- L150201 DENTAL RETRACTORS, REUSABLE EUDAMEDQ010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER 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
Intraoral 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 (5)
- EUDAMED 3259da69-9679-4836-ab3a-7c066aab1bcd 61 fields · synced Jul 31, 2026
- EUDAMED 64d87946-bbe7-4a88-b88a-500d3e61768b 61 fields · synced May 16, 2026
- EUDAMED 800f2047-8193-45a5-8a66-7e549ae965c9 61 fields · synced May 16, 2026
- EUDAMED 946db8c7-4254-4423-b65a-bc491222ccb2 61 fields · synced May 17, 2026
- EUDAMED 4f337552-89a6-4958-a4c1-58351a52830b 61 fields · synced May 18, 2026