Data / Medical devices / Israel / Medical Electronic Systems Ltd.
Medical Electronic Systems Ltd.: FDA-registered device maker in CAESAREA IND. PARK Haifa, Israel, 8 510(k) clearances
Medical Electronic Systems Ltd. is registered with the FDA (registration 3003646592) in CAESAREA IND. PARK Haifa, Israel. It lists 8 device types. The FDA files 8 510(k) clearances under its listings, the newest dated May 2, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003646592
- Address
- Alon Hatavor ST. 20 Zone 6, CAESAREA IND. PARK Haifa, Israel, 3088900
- Owner or operator
- MEDICAL ELECTRONIC SYSTEMS LTD. (9031962)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- April 16, 2008
- Registered through
- 2026
- Brand names listed
- MaleMan Semen Transport Kit, QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS, QWIKCHECK-BEADS, QwikCheck DFI Kit, QwikCheck Dilution Kit, QwikCheck Liquefaction Kit, QwikCheck Test Strip Quality Control, QwikCheck Vitality Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Specimen Mailer And Storage, Sterile | KDT | 1 | Manufacturer | accessdata.fda.gov |
| Eosin Y | HYB | 1 | Manufacturer | accessdata.fda.gov |
| Formulations, Balanced Salt Solutions | KIP | 1 | Manufacturer | accessdata.fda.gov |
| Material, Quality Control, Semen Analysis | NRF | 2 | Manufacturer | accessdata.fda.gov |
| Semen Analysis Device | POV | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Trypsin | IBG | 1 | Manufacturer | accessdata.fda.gov |
| Urinalysis Controls (Assayed And Unassayed) | JJW | 1 | Manufacturer | accessdata.fda.gov |
| Wright'S Stain | IAF | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 2, 2025 | K243114 | SQA-iOw Sperm Quality Analyzer | POV | Substantially Equivalent | Medical Electronic Systems , Ltd. | accessdata.fda.gov |
| November 29, 2024 | K241628 | YO Home Sperm Test | POV | Substantially Equivalent | Medical Electronic Systems , Ltd. | accessdata.fda.gov |
| August 7, 2023 | K220828 | SQA-iO Sperm Quality Analyzer | POV | Substantially Equivalent | Medical Electronic Systems , Ltd. | accessdata.fda.gov |
| November 8, 2016 | K161493 | YO Home Sperm Test | POV | Substantially Equivalent | Medical Electronic Systems , Ltd. | accessdata.fda.gov |
| March 26, 2007 | K063864 | QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS | POV | Substantially Equivalent | Medical Electronic Systems , Ltd. | accessdata.fda.gov |
| July 27, 2004 | K041600 | QWIKCHECK-BEADS | NRF | Substantially Equivalent | Medical Electronics Systems , Ltd. | accessdata.fda.gov |
| September 20, 2002 | K021746 | SQA V, SPERM QUALITY ANALYZER | POV | Substantially Equivalent | Medical Electronic Systems, LLC | accessdata.fda.gov |
| September 21, 2001 | K012352 | SQA, SPERM QUALITY ANALYZER | POV | Substantially Equivalent | Medical Electronic Systems, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Semen Analysis Device
- All makers of Urinalysis Controls (Assayed And Unassayed)
- All makers of Material, Quality Control, Semen Analysis
- All makers of Formulations, Balanced Salt Solutions
- All makers of Wright'S Stain
- All makers of Trypsin
Updated May 2, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.