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Prophy Brush
EUDAMEDClass I (EU MDR)
Ref /Model PB01A,PB01B, PB01C, PB02A, PB02B, PB02C, PB03A, PB03B, PB03C,PB01F, PB01G, PB02F,PB02G,PB03F,PB03G, PB01D,PB01E,PB02D,PB02E,PB03D, PB03ERef PB01F
Identity
- Trade Name
- Prophy Brush EUDAMED
- Device Name
- Prophy Brush EUDAMED
- Model / Reference
- PB01A,PB01B, PB01C, PB02A, PB02B, PB02C, PB03A, PB03B, PB03C,PB01F, PB01G, PB02F,PB02G,PB03F,PB03G, PB01D,PB01E,PB02D,PB02E,PB03D, PB03E EUDAMED/ EUDAMEDPB01F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454002537 EUDAMED06954454002506 EUDAMED06954454002544 EUDAMED06954454002520 EUDAMED06954454015650 EUDAMED
- Basic UDI-DI
- 69544540PRBR001W3 EUDAMED
- EMDN Code
- Q010502 DENTAL POLISHING CUPS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland EUDAMEDGreece EUDAMEDBelgium EUDAMEDGermany EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMEDEUDAMED
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
Prophy Brush by Huanghua Promisee Dental Co.Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dentifrice.
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY · Class I
- Topex® Prophy Paste — Dentsply International · Class I
- Omni — Keystone Industries · Class I
- Disposable Prophy Angles, 105° Contra Angle Clear, Ribbed and Webbed — Premium Plus (Dongguan) Limited · Class IIa
- Dental City — ICP, INC. · Class I
- Blasting Powder — Bioclear Matrix Systems, LLC · Class I
- Enamel Pro® Prophy Paste — PREMIER DENTAL PRODUCTS COMPANY · Class I
- Disposable Prophy Cups, CA Plastic Shank, Ribbed & Webbed Standard — Premium Plus (Dongguan) Limited · Class IIa
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 | 69544540PRBR001W3 | Class I | Active |
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Manufacturer
- Manufacturer
- Huanghua Promisee Dental Co.Ltd.
- EUDAMED SRN
- CN-MF-000014766
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (5)
- EUDAMED 3d84e8a1-07f3-44d0-8a4e-68086c22fb35 61 fields · synced Jul 11, 2026
- EUDAMED 07002898-c92a-4699-89b5-2b9ccd42cf62 61 fields · synced May 17, 2026
- EUDAMED e817e6b4-4ca6-4e09-8a54-0392b01d37be 61 fields · synced May 18, 2026
- EUDAMED de8ac1bd-0bc1-4e19-84c6-850b1007143e 61 fields · synced May 18, 2026
- EUDAMED 29f0d870-2422-44f3-86a6-041fc5da3a81 61 fields · synced Jul 8, 2026