FDA Registration
Active
🇮🇱 Israel
MEDICAL ELECTRONIC SYSTEMS LTD.
Reg #: 3003646592
·
FEI: 3003646592
·
Expires 2026
Products
8
Proprietary Names
15
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- MEDICAL ELECTRONIC SYSTEMS LTD.
- Registration Number
- 3003646592
- FEI Number
- 3003646592
- Status
- Active
- Expiry Year
- 2026
- 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 |
| Material, Quality Control, Semen Analysis | NRF | Class 2 | Hematology | No | 2014-12-12 |
| Urinalysis Controls (Assayed And Unassayed) | JJW | Class 1 | Clinical Chemistry | No | 2014-12-12 |
| Eosin Y | HYB | Class 1 | Hematology | No | 2023-02-01 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2025-02-11 |
| Formulations, Balanced Salt Solutions | KIP | Class 1 | Hematology | No | 2022-12-29 |
| Wright'S Stain | IAF | Class 1 | Hematology | No | 2022-09-19 |
| Trypsin | IBG | Class 1 | Pathology | No | 2014-12-12 |
Proprietary Names
SQA-Vision; SQA-V; SQA Sperm Quality Analyzer
SQA-iOw Sperm Quality Analyzer
SQA-iO Sperm Quality Analyzer
QWIKCHECK-BEADS
YO Home Sperm Test
QwikCheck Vitality Kit
Semen Preservative (pack of 50/ 5mL) single use vials for semen transportation/ preservation
MaleMan Semen Transport Kit
QwikCheck Dilution Kit
QwikCheck Proficiency and Training Kit
QwikCheck Beads Precision and Linearity Kit
QwikCheck DFI Kit
QwikCheck Test Strip Quality Control
QwikCheck Liquefaction Kit
QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device