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Disposable Prophy Angles, 105° Contra Angle, Flat Brush
EUDAMEDClass IIa (EU MDR)
Ref 3399-105F
Identity
- Trade Name
- Disposable Prophy Angles, 105° Contra Angle, Flat Brush EUDAMED
- Device Name
- Dental Prophy Angles EUDAMED
- Model / Reference
- 3399-105F EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D1253399105F2 EUDAMED
- Basic UDI-DI
- ++D125PROPHYANGLESTN EUDAMED
- Unit of Use DI
- 2 EUDAMED
- EMDN Code
- Q010502 DENTAL POLISHING CUPS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa 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
Disposable Prophy Angles, 105° Contra Angle, Flat Brush by Premium Plus (Dongguan) Limited — Class IIa — 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 | ++D125PROPHYANGLESTN | Class IIa | 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 (1)
- EUDAMED 76ae85ec-01e1-4ac3-9f86-3cd8c567c6cf 61 fields · synced Jun 17, 2026