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Medical Electronic Systems , Ltd.

Israel · Caesarea Ind. Park Haifa

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Singapore — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

8listed device types

Class I 6Class II 2Class III 0

plus 15 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States15 registration records, 7 510(k), 0 PMA, 260 excluded

Brazil1 confirmed, 62 excluded

Saudi Arabia0 confirmed, 15 excluded

Canada0 confirmed, 25 excluded

Manufacturer names merged into this page: MEDICAL ELECTRONIC SYSTEMS LTD. · MEDICAL ELECTRONIC SYSTEMS LTD

FDA 510(k) clearances by year

12001

12002

12007

12016

12023

12024

12025

FDA listed device types

Semen Analysis Device 1Material, Quality Control, Semen Analysis 1Urinalysis Controls (Assayed And Unassayed) 1Container, Specimen Mailer And Storage, Sterile 1Formulations, Balanced Salt Solutions 1Trypsin 1Eosin Y 1Wright'S Stain 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243114	SQA-iOw Sperm Quality Analyzer	2025-05-02
US	K241628	YO Home Sperm Test	2024-11-29
US	K220828	SQA-iO Sperm Quality Analyzer	2023-08-07
BR	81678060015	ANALISADOR DE QUALIDADE DE ESPERMA SQA-iO	Class II

Medical Electronic Systems , Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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