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Ultrasonic Diagnostic System
EUDAMEDClass IIa (EU MDR)
Ref Clover 50T Model Clover 50TModel Clover 50, Clover 60, Clover 70, Clover 50T, Clover 60T, Clover w, Clover i, Clover s
Identity
- Trade Name
- Ultrasonic Diagnostic System EUDAMED
- Device Name
- Ultrasonic Diagnostic System EUDAMED
- Model / Reference
- Clover 50T EUDAMEDClover 50, Clover 60, Clover 70, Clover 50T, Clover 60T, Clover w, Clover i, Clover s EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971355420369 EUDAMED
- Basic UDI-DI
- B-06971355420369 EUDAMED697135542U03P6 EUDAMED
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) 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
Ultrasonic Diagnostic System by Shenzhen Wisonic Medical Technology Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06971355420369 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06971355420369 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Wisonic Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005656
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 8a16fa7f-aa90-4620-86f8-8dd544b8af44 61 fields · synced Oct 6, 2026
- EUDAMED 76fe99dc-dd23-4c8c-a63e-4062a646c0b7 61 fields · synced May 19, 2026