FDA.reportPublic FDA data

ACIST EUROPE BV

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30120446883012044688ACIST EUROPE BV1N2026-01-01Argonstraat 3 Heerlen Limburg NL 6422PH

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3049461210616506K974621PERCUPUMP II WITH EDADSB1998-01-27
3049461398937757K933846ANGIOGRAPHY SYRINGE KITSDXT1994-12-13
3049461649375007K932055PERCUPUMP IIFIH1995-03-21
3049461197253683K062449EMPOWERMR INJECTOR SYSTEM, MODEL 9730IZQ2007-04-13
3049462013624153

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IZQ12007-04-13
DSB11998-01-27
FIH11995-03-21
DXT11994-12-13