Identity
- Trade Name
- Terason 5C2A EUDAMEDTerason FDA UDI
- Generic Name
- Hand-held ultrasound imaging system, body-surface FDA UDI
- Device Name
- 5C2A Transducer EUDAMEDThe Terason 15L4 transducer is a general-purpose, high-frequency linear transducer array. The intended uses include: ophthalmic, abdominal, pediatric, small organ, musculoskeletal (conventional and superficial), and peripheral vascular ultrasound imaging. FDA UDI
- Model / Reference
- Terason 5C2A EUDAMED10-3278 EUDAMED15L4 FDA UDI
- Description
- The Terason 15L4 transducer is a general-purpose, high-frequency linear transducer array. The intended uses include: ophthalmic, abdominal, pediatric, small organ, musculoskeletal (conventional and superficial), and peripheral vascular ultrasound imaging. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852698007010 EUDAMEDFDA UDI
- Basic UDI-DI
- 852698007010HS EUDAMED
- Direct Marketing DI
- 00852698007010 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 5C2A 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 | 852698007010HS | 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 f980471a-83fb-48c8-9cad-ef3dbd81e47e 61 fields · synced Jul 10, 2026
- FDA UDI 1e9e6491-e701-4c92-911b-4336fa3c0ab6 34 fields · synced May 30, 2026