Identity
- Device Name
- Prophy Brush EUDAMED
- Model / Reference
- Card type EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975702480020 EUDAMED
- Basic UDI-DI
- 697570248PB01LG EUDAMED
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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: Dental material injection cannula, single-use
Prophy Brush by Dongguan Ouwen Medical Device Technology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697570248PB01LG | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Ouwen Medical Device Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000013171
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED b1fd56c8-5527-4286-a97f-736411db27b2 61 fields · synced Jul 11, 2026