FDA Registration
Active
🇮🇱 Israel
SQA-Vision; SQA-V; SQA Sperm Quality Analyzer
Reg #: 3003646592
·
FEI: 3003646592
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- MEDICAL ELECTRONIC SYSTEMS LTD.
- Registration Number
- 3003646592
- FEI Number
- 3003646592
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ALON HATAVOR ST. 20 ZONE 6
- City
- CAESAREA IND. PARK Haifa
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K021746
Owner / Operator
- Firm Name
- MEDICAL ELECTRONIC SYSTEMS LTD.
- Operator Number
- 9031962
- Address
- ALON HATAVOR ST. 20 ZONE 6, --
- City
- CAESAREA IND. PARK
- State
- IL-NOTA
- Postal Code
- 3088900
- Country
- IL
- Correspondent
- MARCIA - DEUTSCH
US Agent
- Business Name
- Medical Electronic Systems LLC
- Contact Name
- Eric Carver
- Address
- 6345 Balboa Blvd., Suite 185
- City
- Encino
- State
- CA
- ZIP
- 91316
- Country
- US
- [email protected]
- Phone
- 818 9171074
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Semen Analysis Device | POV | Class 2 | Hematology | No | 2008-04-16 |
Proprietary Names
SQA-Vision; SQA-V; SQA Sperm Quality Analyzer
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device