Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003646592

FEI Number

3003646592

Entity Name

MEDICAL ELECTRONIC SYSTEMS LTD.

City/State/Country

CAESAREA IND. PARK Haifa, IL

Establishment Address

ALON HATAVOR ST. 20 ZONE 6, CAESAREA IND. PARK Haifa 3088900, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEDICAL ELECTRONIC SYSTEMS LTD. (Owner Number: 9031962)

Owner / Operator Contact Address

ALON HATAVOR ST. 20 ZONE 6, --, CAESAREA IND. PARK, IL-NOTA 3088900, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 SQA-Vision; SQA-V; SQA Sperm Quality Analyzer QwikCheck Vitality Kit Semen Preservative (pack of 50/ 5mL) single use vials for semen transportation/ preservation MaleMan Semen Transport Kit YO Home Sperm Test QwikCheck Dilution Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
POV	Semen Analysis Device	Hematology	Class 2	864.5220	2008-04-16
POV	Semen Analysis Device	Hematology	Class 2	864.5220	2025-05-07
POV	Semen Analysis Device	Hematology	Class 2	864.5220	2023-09-05
NRF	Material, Quality Control, Semen Analysis	Hematology	Class 2	864.8625	2014-12-12
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-12-12
POV	Semen Analysis Device	Hematology	Class 2	864.5220	2016-11-17
POV	Semen Analysis Device	Hematology	Class 2	864.5220	2010-01-21
HYB	Eosin Y	Hematology	Class 1	864.1850	2023-02-01
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2025-02-11
POV	Semen Analysis Device	Hematology	Class 2	864.5220	2024-12-16
KIP	Formulations, Balanced Salt Solutions	Hematology	Class 1	864.2875	2022-12-29

Official Correspondent

MARCIA DEUTSCH

US Agent Details

Eric Carver Business: Medical Electronic Systems LLC Email: eric@mes-llc.com Phone: (818) 9171074

Related Public Records

Same Entity

MEDICAL ELECTRONIC SYSTEMS LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003646592. Last updated year: 2026. Please use registration number 3003646592 when referencing this establishment in official correspondence.