FDA.reportPublic FDA data

Coloplast Manufacturing US, LLC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30300876933030087693Coloplast Manufacturing US, LLC.1Y2026-01-014008 Heritage Drive Brookshire TX US 77423

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3231821881526356K223821Self-Cath Closed SystemFCM2023-08-02
3231821180206725K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture SetsLJE2022-03-10
3231821100181905K121833OSTOMY IRRIGATION SETEXD2012-07-16
3231821194037049
3231821471863104
3231821476228152
3231821554983951
3231821796124895

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FCM12023-08-02
LJE12022-03-10
EXD12012-07-16