← Back to catalogue
Ultrasonic Diagnostic System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Clover 50Model Clover 50, Clover 60, Clover 70, Clover 50T, Clover 60T, Clover w, Clover i, Clover s
Identity
- Trade Name
- Ultrasonic Diagnostic System EUDAMEDWISONIC FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Ultrasonic Diagnostic System EUDAMED
- Model / Reference
- Clover 50, Clover 60, Clover 70, Clover 50T, Clover 60T, Clover w, Clover i, Clover s EUDAMEDClover 50 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971355420017 EUDAMEDFDA UDI
- Basic UDI-DI
- 697135542U03P6 EUDAMEDB-06971355420017 EUDAMED
- FDA Product Code
- ITX FDA UDIIYN FDA UDIIYO FDA UDI
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1550 FDA UDI892.1560 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ultrasonic Diagnostic System by Shenzhen Wisonic Medical Technology Co., Ltd. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697135542U03P6 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697135542U03P6 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
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 (3)
- EUDAMED 3dad98cc-0639-4b82-94d9-f7422e7b5cf0 61 fields · synced Oct 6, 2026
- EUDAMED 7dca225d-12ba-463e-ab65-7494edc1ce91 61 fields · synced May 19, 2026
- FDA UDI 0b8c8753-6a1b-4aa8-bf97-f2b634da862e 32 fields · synced May 30, 2026