Identity
- Trade Name
- Prophy Paste EUDAMED
- Device Name
- Prophy Paste EUDAMED
- Model / Reference
- PC05M, PC05F EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454007112 EUDAMED06954454007150 EUDAMED06954454007334 EUDAMED06954454007037 EUDAMED06954454006535 EUDAMED
- Basic UDI-DI
- 69544540PRPA001X6 EUDAMED
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland EUDAMEDGermany EUDAMEDFrance EUDAMEDBelgium 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
Prophy Paste by Huanghua Promisee Dental Co.Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69544540PRPA001X6 | 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 c30e8de5-cb41-48b6-b165-1a882cb5df3c 61 fields · synced Oct 6, 2026
- EUDAMED f417992b-f320-4506-b023-c7711aea748b 61 fields · synced May 16, 2026
- EUDAMED 05cc30c9-e1f0-4088-91c3-23744e60bbcc 61 fields · synced May 17, 2026
- EUDAMED 6dc455e3-b035-4314-82af-2a08321a017c 61 fields · synced May 18, 2026
- EUDAMED 6a02a0c4-0e9d-48a8-96db-5f820593efd8 61 fields · synced May 18, 2026