FDA.reportPublic FDA data

MOTILITYCOUNT APS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30155506583015550658MOTILITYCOUNT APS1N2026-01-01Gl. Koege Landevej 57 2 Valby Hovedstaden DK DK-2500

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2319921282878890K241348SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)MQK2025-01-31
2319921644878283K183602SwimCount Sperm Quality TestPOV2019-06-27

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQK12025-01-31
POV12019-06-27

PMN#

GUDID#