← Back to catalogue
Terason uSmart3200T USB3
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10-3232 R200Model Terason uSmart3200T USB3
Identity
- Trade Name
- Terason uSmart3200T USB3 EUDAMEDTerason FDA UDI
- Generic Name
- Hand-held ultrasound imaging system, body-surface FDA UDI
- Device Name
- uSmart3200T Ultrasound System, Tablet USB3 EUDAMEDTerason uSmart3200T R2/Nexgen ultrasound system FDA UDI
- Model / Reference
- Terason uSmart3200T USB3 EUDAMED10-3232 R200 EUDAMEDuSmart3200T FDA UDI
- Description
- Terason uSmart3200T R2/Nexgen ultrasound system FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852698007218 EUDAMEDFDA UDI
- Basic UDI-DI
- 852698007218JL EUDAMED
- Direct Marketing DI
- 00852698007218 EUDAMED
- FDA Product Code
- IYO FDA UDIIYN FDA UDIITX FDA UDI
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- Hand-held ultrasound imaging system, body-surface FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1550 FDA UDI892.1570 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
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Terason uSmart3200T USB3 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 | 852698007218JL | 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
- Teratech Corporation
- EUDAMED SRN
- US-MF-000033295
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED fd7f9d21-08ec-48cb-b5e5-5fbed8634e57 61 fields · synced Jul 21, 2026
- FDA UDI 04c08b73-b1b9-4773-bd20-ab6b71917c38 34 fields · synced May 30, 2026