Identity
- Trade Name
- Terason 12L5A EUDAMEDTerason FDA UDI
- Generic Name
- Hand-held ultrasound imaging system, body-surface FDA UDI
- Device Name
- 12L5A Transducer EUDAMEDThe Terason 12L5A 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 12L5A EUDAMED10-3276 EUDAMED12L5A FDA UDI
- Description
- The Terason 12L5A 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
- 00852698007096 EUDAMEDFDA UDI
- Basic UDI-DI
- 852698007096JW EUDAMED
- Direct Marketing DI
- 00852698007096 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 12L5A 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 | 852698007096JW | 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 e1d87545-60c6-4717-a7bf-8b9f50ef035b 61 fields · synced Jun 18, 2026
- FDA UDI d33ba206-8815-4ea9-834a-2c2f33543b98 34 fields · synced May 30, 2026