FDA.reportPublic FDA data

ASCENSIA DIABETES CARE HOLDINGS AG

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30121186593012118659ASCENSIA DIABETES CARE HOLDINGS AG1N2026-01-01Peter Merian-Strasse 90 Basel Basel-Stadt CH CH-4052

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2544691534525097P160017MiniMed 670G SystemOZP2016-09-28
2544691492555049P150001MINIMED 630G SYSTEM WITH SMARTGUARD(TM)OZO2016-08-10
2544691056493549K831600DIASTIX REAGENT STRIPS FOR URINALYSISJIL1983-09-08
2544691337358993K801270TEST FOR KETONE IN URINE(ACETOACETIC ACJIN1980-07-08
2544691247890607K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring SystemNBW2026-08-27
2544691998431943K241810MICROLET®NEXT LancetQRK2024-08-15
2544691724761781K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring SystemNBW2024-08-27
2544691129702752K231679CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemNBW2024-02-23
2544691147758777K223293CONTOUR® NEXT GEN Blood Glucose Monitoring SystemNBW2022-11-18
2544691067755245K220633MICROLET NEXT lancing device, MICROLET LancetQRL2022-06-03
2544691214897858K210687CONTOUR® NEXT ONE Blood Glucose Monitoring SystemNBW2021-08-11
2544691598915488K193407Contour® next GEN Blood Glucose Monitoring SystemNBW2021-12-23
2544691950158680K191286CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring SystemNBW2019-11-08
2544691958727235K162336Contour Next EZ Blood Glucose Monitoring SystemNBW2017-01-12
2544691302816265K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemNBW2016-11-17
2544691446117500K160430Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring SystemNBW2016-06-24
2544691700819276K151742Contour Next Control SolutionJJX2015-09-23
2544691211802849K130265CONTOUR NEXT EZ BLOOD GLUCOSE METERNBW2014-06-23
2544691416442507K122370CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITORNBW2013-09-26
2544691924960678K121190CONTOUR NEXT BLOOD GLUCOSE METERLFR2012-07-26
2544691031641593K121087CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEMNBW2012-06-28
2544691047308950K111268CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEMLFR2012-03-06
2544691709821602K110894CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METERLFR2012-03-28
2544692042901743K091820CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEMNBW2009-08-26
2544691020370375K090628DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080NBW2009-12-04
2544691376525541K062058ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080NBW2006-09-11
2544691445068292
2544691088615311
2544691190557141
2544691243925699

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW162026-08-27
LFR32012-07-26
QRK12024-08-15
QRL12022-06-03
OZP12016-09-28
OZO12016-08-10
JJX12015-09-23
JIL11983-09-08
JIN11980-07-08