FDA.reportPublic FDA data

Coloplast A/S - Mordrup Site

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30113070483011307048Coloplast A/S - Mordrup Site1N2026-01-01Aa. Louis-Hansens Alle 15 Espergaerde Hovedstaden DK 3060

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1759491857604852K180258SpeediCath StandardGBM2018-10-25
1759491836703167K143182Speedicath Compact MaleGBM2015-01-20
1759491498251775K121458SPEEDICATH COMPACT SET (12/18 FR)GBM2012-10-01
1759491923071866K023254SPEEDICATHGBM2003-01-27
1759491398980614
1759491471863104
1759491554983951

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GBM42018-10-25