Identity
- Trade Name
- Disposable Prophy Cups, Screw-In, Point EUDAMED
- Device Name
- Dental Prophy Cups EUDAMED
- Model / Reference
- 226RA EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125226RA2 EUDAMED
- Basic UDI-DI
- ++D125PROPHYCUPSBS 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
Category: Dentifrice
Disposable Prophy Cups, Screw-In, Point by Premium Plus (Dongguan) Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dentifrice.
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- Omni — Keystone Industries · 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 | ++D125PROPHYCUPSBS | 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 c2bedde5-a8b3-4add-84e0-59ee08167c69 61 fields · synced Jun 18, 2026