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Prophy Cup
EUDAMEDClass I (EU MDR)
Ref /Model PC01A,PC01B, PC02A, PC02B, PC03A, PC03B, PC04A, PC04B
Identity
- Trade Name
- Prophy Cup EUDAMED
- Device Name
- Prophy Cup EUDAMED
- Model / Reference
- PC01A,PC01B, PC02A, PC02B, PC03A, PC03B, PC04A, PC04B EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454002605 EUDAMED
- Basic UDI-DI
- 69544540PRCU001X3 EUDAMED
- EMDN Code
- Q010502 DENTAL POLISHING CUPS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Prophy Cup 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 | 69544540PRCU001X3 | 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 (1)
- EUDAMED ac897442-0407-43a2-a2db-316defc2c922 61 fields · synced Jun 17, 2026