FDA Registration
Active
🇮🇱 Israel
TECHSOMED
Reg #: 3030089065
·
FEI: 3030089065
·
Expires 2026
Products
5
Proprietary Names
3
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- TECHSOMED
- Registration Number
- 3030089065
- FEI Number
- 3030089065
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6 Ofra Haza St.
- City
- Or Yehuda Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K243084
Owner / Operator
- Firm Name
- Techsomed
- Operator Number
- 10089374
- Address
- Meir Weisgal 2
- City
- Rehovot
- State
- Southern
- Postal Code
- 7632605
- Country
- IL
- Correspondent
- Dalia Dickman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Post-Ablation Tissue Response Prediction Software | QZL | Class 2 | Radiology | No | 2025-04-10 |
| Radiological Image Processing Software For Ablation Therapy Planning And Evaluation | QTZ | Class 2 | Radiology | No | 2026-03-24 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2026-03-24 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2026-03-24 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2025-04-10 |
Proprietary Names
BioTrace.IO Precision 2
BioTraceIO Vision
BioTrace.IO 360
Establishment Types
Manufacture Medical Device