Identity
- Trade Name
- Terason 4V2A EUDAMEDTerason FDA UDI
- Generic Name
- Hand-held ultrasound imaging system, body-surface FDA UDI
- Device Name
- 4V2A Transducer EUDAMEDTerason phased array transducer 4V2A. The intended uses for this transducer include: fetal, abdominal, pediatric, neonatal and adult cephalic and both adult and pediatric cardiac ultrasound imaging. FDA UDI
- Model / Reference
- Terason 4V2A EUDAMED10-3216 EUDAMED4V2A FDA UDI
- Description
- Terason phased array transducer 4V2A. The intended uses for this transducer include: fetal, abdominal, pediatric, neonatal and adult cephalic and both adult and pediatric cardiac ultrasound imaging. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852698007027 EUDAMEDFDA UDI
- Basic UDI-DI
- 852698007027JB EUDAMED
- Direct Marketing DI
- 00852698007027 EUDAMED
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z11040299 ULTRASOUND PROBES – OTHER EUDAMED
- GMDN Term
- Hand-held ultrasound imaging system, body-surface FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- Northern Ireland 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
No
FDA UDI
Terason 4V2A by Teratech Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 852698007027JB | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Teratech Corporation
- EUDAMED SRN
- US-MF-000033295
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED 333b9422-a82a-40c2-8740-4c14f4a58853 61 fields · synced Aug 3, 2026
- FDA UDI f22d2172-b54d-4ac6-a7ab-2d55b9865b76 34 fields · synced May 30, 2026