Identity
- Trade Name
- Ultrasonic Scaler EUDAMED
- Device Name
- Ultrasonic Scaler EUDAMED
- Model / Reference
- DA-10、DA-20、VRN-Q5 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740742771 EUDAMED
- Basic UDI-DI
- 69357404MZ1211DA001NU EUDAMED
- Direct Marketing DI
- 06935740742771 EUDAMED
- EMDN Code
- L159009 ODONTOSTOMATOLOGY SCALERS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Ultrasonic Scaler by URIT Medical Electronic Co., Ltd. — Class IIa — 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 | 69357404MZ1211DA001NU | Class IIa | Active |
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Manufacturer
- Manufacturer
- URIT Medical Electronic Co., Ltd.
- EUDAMED SRN
- CN-MF-000011840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED fd8d1ba5-f30e-4834-b8ec-af0ade2de209 61 fields · synced Jun 19, 2026