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Disposable Prophy Cups, CA Metal Shank, Point
EUDAMEDClass IIa (EU MDR)
Ref 225LBRef 225XARef PD003837Ref 225PKRef 225RARef 225DBRef 225WTRef 225SARef 225LV
Identity
- Trade Name
- Disposable Prophy Cups, CA Metal Shank, Point EUDAMED
- Device Name
- Dental Prophy Cups EUDAMED
- Model / Reference
- 225LB EUDAMED225XA EUDAMEDPD003837 EUDAMED225PK EUDAMED225RA EUDAMED225DB EUDAMED225WT EUDAMED225SA EUDAMED225LV EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125225LB2 EUDAMED+D125225XA2 EUDAMED+D125FIPD0038372 EUDAMED+D125225PK2 EUDAMED+D125225RA2 EUDAMED+D125225DB2 EUDAMED+D125225WT2 EUDAMED+D125225SA2 EUDAMED+D125225LV2 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, CA Metal Shank, Point by Premium Plus (Dongguan) Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dentifrice.
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY · Class I
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- Blasting Powder — Bioclear Matrix Systems, LLC · Class I
- Enamel Pro® Prophy Paste — PREMIER DENTAL PRODUCTS COMPANY · Class I
- Prophy Brush — Huanghua Promisee Dental Co.Ltd. · Class I
- 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 (9)
- EUDAMED 4b20bfe0-5ad4-402d-b44c-bbad62a9aace 61 fields · synced Sep 18, 2026
- EUDAMED 33604261-a8d4-41d1-b00f-086694cbe163 61 fields · synced May 16, 2026
- EUDAMED 9c78fec6-c56c-432d-9cfb-6088c0b389f1 61 fields · synced May 16, 2026
- EUDAMED d73cd0e0-873a-46e2-b685-a75b062f91b2 61 fields · synced May 16, 2026
- EUDAMED 4b93a8d7-98db-4ab3-a182-4b646d046035 61 fields · synced May 17, 2026
- EUDAMED dfdab11d-348e-4730-9b01-7488e9bb64f7 61 fields · synced May 17, 2026
- EUDAMED 8b31271f-1fcc-43e2-b6a4-4b8b967c1651 61 fields · synced May 18, 2026
- EUDAMED 9983716e-7793-454e-8a81-038e4047c63a 61 fields · synced May 18, 2026
- EUDAMED 31ffe96e-b98b-4d4b-9416-c98887237d47 61 fields · synced May 18, 2026