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Terason uSmart3200T Plus
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10-3258Model Terason uSmart3200T PlusRef 10-3232Model Terason
Identity
- Trade Name
- Terason uSmart3200T Plus EUDAMEDTerason uSmart3200T EUDAMEDTerason FDA UDI
- Generic Name
- Hand-held ultrasound imaging system, body-surface FDA UDI
- Device Name
- uSmart3200T Plus Ultrasound System without GPU, Tablet EUDAMEDuSmart3200T Ultrasound System, Tablet EUDAMEDThe Terason uSmart3200T is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intraoperative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-cardiac), Musculoskeletal (Conventional and Superficial), Cardiac (Adult & Pediatric), Trans-esophageal (cardiac), and Peripheral Vascular. FDA UDITerason uSmart3200T PLUS ultrasound system FDA UDI
- Model / Reference
- Terason uSmart3200T Plus EUDAMED10-3258 EUDAMEDTerason EUDAMED10-3232 EUDAMEDuSmart3200T FDA UDIuSmart3200T Plus FDA UDI
- Description
- The Terason uSmart3200T is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intraoperative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-cardiac), Musculoskeletal (Conventional and Superficial), Cardiac (Adult & Pediatric), Trans-esophageal (cardiac), and Peripheral Vascular. FDA UDITerason uSmart3200T PLUS ultrasound system FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852698007508 EUDAMEDFDA UDI00852698007119 EUDAMEDFDA UDI
- Basic UDI-DI
- 852698007508JY EUDAMED852698007119JH EUDAMED
- Direct Marketing DI
- 00852698007508 EUDAMED00852698007119 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
No
FDA UDIFDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDIFDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Terason uSmart3200T Plus 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 | 852698007508JY | 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 (4)
- EUDAMED ae3fa6c0-57cb-4e8a-b98d-4fca4fdc17f9 61 fields · synced Jul 10, 2026
- FDA UDI 1da91237-8bb8-4fe4-9b1f-172a9a17bc36 34 fields · synced May 30, 2026
- FDA UDI 3ac960fd-eb38-4542-a8fe-65bb393bea8d 34 fields · synced May 30, 2026
- EUDAMED 2a874bee-5e5c-4f91-a743-c91dcc32e7a6 61 fields · synced Jul 10, 2026