MEDICAL ELECTRONIC SYSTEMS LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30036465923003646592MEDICAL ELECTRONIC SYSTEMS LTD.1N2026-01-01ALON HATAVOR ST. 20 ZONE 6 CAESAREA IND. PARK Haifa IL 3088900

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
173991394453539K243114SQA-iOw Sperm Quality AnalyzerPOV2025-05-02
173991127977604K241628YO Home Sperm TestPOV2024-11-29
173992024043695K220828SQA-iO Sperm Quality AnalyzerPOV2023-08-07
173991546696516K161493YO Home Sperm TestPOV2016-11-08
173991397905323K063864QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSISPOV2007-03-26
173991989010732K041600QWIKCHECK-BEADSNRF2004-07-27
173991185367250K021746SQA V, SPERM QUALITY ANALYZERPOV2002-09-20
173991871759368K012352SQA, SPERM QUALITY ANALYZERPOV2001-09-21
173992027801047
173991168461181
173991223961304
173991235881306
173991738854613
173991992418907
173992035368774

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
POV112025-05-02
NRF22004-07-27

PMN#