Identity
- Trade Name
- Prophy cup EUDAMED
- Device Name
- Prophy cup EUDAMED
- Model / Reference
- 9001/120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973163112054 EUDAMED
- Basic UDI-DI
- 697316311DPA00005D5 EUDAMED
- EMDN Code
- Q010502 DENTAL POLISHING CUPS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Prophy cup by Suzhou Pac-Dent Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dentifrice.
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- Enamel Pro® Prophy Paste — PREMIER DENTAL PRODUCTS COMPANY · Class I
- Prophy Brush — Huanghua Promisee Dental Co.Ltd. · 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 | 697316311DPA00005D5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Suzhou Pac-Dent Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000021642
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (1)
- EUDAMED 2abeda23-73e6-4d84-a208-c2b22626c7c5 61 fields · synced Jun 18, 2026