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ASP Global Manufacturing GmbH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30153924013015392401ASP Global Manufacturing GmbH1N2026-01-01Im Majorenacker 10 SCHAFFHAUSEN CH 8207

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2910561834868600K991999STERRAD 100S STERILIZERMLR2000-06-15
2910561146037432K242453Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)FRC2024-12-12
2910562001220231K232103Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)QKM2024-04-05
2910561779485158K221641Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)FRC2023-02-28
2910561102758100K200272Terragene ChemdyeJOJ2020-06-30
2910562070955450K191021Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene ChemdyeFRC2019-09-13
2910561943372035K181472AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC MonitorFEB2019-04-23
2910561300725240K163646Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader IncubatorFRC2017-11-02
2910561449483644K163598Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical IndicatorKCT2017-07-31
2910561820249017K160903STERRAD 100NX Sterilizer with ALLClearTM TechnologyMLR2016-09-26
2910561139076008K160818STERRAD® NX Sterilizer with ALLClear™ TechnologyMLR2016-09-27
2910561189690154K142454STERRAD NX Sterilizer, STERRAD 100NX SterilizerMLR2015-04-03
2910561309170011K111377STERRAD(R) 100NX STERILIZER DUO CYCLEMLR2012-09-13
2910561212537115K092622STERRAD 100NX STERILIZER EXPRESS CYCLEMLR2011-03-04
2910561508546641K081427BROWNE OPA TEST STRIPJOJ2008-06-11
2910561331967271K071385STERRAD 100NX STERILIZERMLR2007-11-29
2910561770522077K042116STERRAD NX STERILIZERMLR2005-04-22
2910561673180376K032959CIDEX OPA CONCENTRATEMED2005-04-04
2910561071047082K0300040.55% ORTH-PHTHALALDEHYDE SOLUTIONMED2003-02-27
2910561171513659K023290STERRAD 50 & STERRAD 100S STERILIZERSFLF2003-04-03
2910561267102946DEN220042Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)QVB2024-07-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MLR82016-09-27
FRC42024-12-12
JOJ22020-06-30
MED22005-04-04
QVB12024-07-12
QKM12024-04-05
FEB12019-04-23
KCT12017-07-31
FLF12003-04-03