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Ultrasonic Diagnostic System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Labat TEModel Labat SE/Labat SP/Labat SG/Labat PE/Labat PG/Labat TE/Labat TG/Labat IE/Labat IG
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
- Labat SE/Labat SP/Labat SG/Labat PE/Labat PG/Labat TE/Labat TG/Labat IE/Labat IG EUDAMEDLabat TE EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971355420635 EUDAMEDFDA UDI
- Basic UDI-DI
- 697135542U02P4 EUDAMED
- 510(k) Number
- K210154 FDA UDI
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX 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
- 892.1550 FDA UDI892.1560 FDA UDI892.1570 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
MR Unsafe FDA UDI
Ultrasonic Diagnostic System by Shenzhen Wisonic Medical Technology Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697135542U02P4 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 219262ba-2952-45e6-a6dd-1d0acdada959 61 fields · synced Jul 13, 2026
- FDA UDI 52557ddb-7ce2-4422-ab70-c46af06ab259 33 fields · synced May 30, 2026