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Disposable Prophy Brushes, CA Shank, Junior Cup
EUDAMEDClass IIa (EU MDR)
Ref X-268Ref S-268-20Ref PD003029Ref R-268-20Ref R-268Ref PD003027Ref R-268ARef S-268Ref PD003028Ref S-268A
Identity
- Trade Name
- Disposable Prophy Brushes, CA Shank, Junior Cup EUDAMED
- Device Name
- Dental Prophy Brushes EUDAMED
- Model / Reference
- X-268 EUDAMEDS-268-20 EUDAMEDPD003029 EUDAMEDR-268-20 EUDAMEDR-268 EUDAMEDPD003027 EUDAMEDR-268A EUDAMEDS-268 EUDAMEDPD003028 EUDAMEDS-268A EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125X2682 EUDAMED+D125S268204 EUDAMED+D125FIPD0030292 EUDAMED+D125R268204 EUDAMED+D125R2682 EUDAMED+D125FIPD0030272 EUDAMED+D125R268A2 EUDAMED+D125S2682 EUDAMED+D125FIPD0030282 EUDAMED+D125S268A2 EUDAMED
- Basic UDI-DI
- ++D125PROPHYBRUSHES5P EUDAMED
- Unit of Use DI
- 2 EUDAMED4 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 Brushes, CA Shank, Junior Cup 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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- 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 | ++D125PROPHYBRUSHES5P | 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 (10)
- EUDAMED 516b7df2-bd87-4f6a-9c82-14249104f3b9 61 fields · synced Sep 17, 2026
- EUDAMED 02467b4a-1ce2-47d3-88c4-ee28af0f3dde 61 fields · synced May 16, 2026
- EUDAMED edd4fbdf-c4fc-41d4-ba7e-ff2ed72d574d 61 fields · synced May 17, 2026
- EUDAMED 88551221-b9c3-4b47-accc-5e4a3ac3655b 61 fields · synced May 17, 2026
- EUDAMED 75aec185-217b-4614-858c-b8dcbc581771 61 fields · synced May 17, 2026
- EUDAMED 9e0b1b57-be03-4ec3-b3ac-001b4322573d 61 fields · synced May 18, 2026
- EUDAMED 9218e91d-b6f3-455a-bede-af8b037ebb9a 61 fields · synced May 18, 2026
- EUDAMED 71f0f93b-48f8-4e5b-8c25-7494ebc4a56d 61 fields · synced May 18, 2026
- EUDAMED bcd5321e-203c-44cd-afbc-23875b3de80d 61 fields · synced May 19, 2026
- EUDAMED d1e1a3b5-c869-4446-b1ca-200c99b60368 61 fields · synced May 19, 2026