Identity
- Trade Name
- Terason 8V3A EUDAMEDTerason FDA UDI
- Generic Name
- Hand-held ultrasound imaging system, body-surface FDA UDI
- Device Name
- 8V3A Transducer EUDAMEDThe Terason 8V3A is a high-frequency, phase-array transducer. The intended uses include: fetal, abdominal, pediatric, neonatal and adult cephalic, and adult and pediatric cardiac ultrasound imaging. FDA UDI
- Model / Reference
- Terason 8V3A EUDAMED10-3329 EUDAMED8V3A FDA UDI
- Description
- The Terason 8V3A is a high-frequency, phase-array transducer. The intended uses include: fetal, abdominal, pediatric, neonatal and adult cephalic, and adult and pediatric cardiac ultrasound imaging. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852698007058 EUDAMEDFDA UDI
- Basic UDI-DI
- 852698007058JN EUDAMED
- Direct Marketing DI
- 00852698007058 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 8V3A 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 | 852698007058JN | 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 95d774f3-a917-425b-9a2c-7e03ba33ef5f 61 fields · synced Jun 18, 2026
- FDA UDI 95e64a1d-67e8-49a1-85a2-d1ce2ce72ba4 34 fields · synced May 30, 2026