Apex Biotechnology Corp

FDA Filings

This page includes the latest FDA filings for Apex Biotechnology Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

TAIWANTAIWAN STOCK EXCHANGE1733DUNS 657608092
FDA Registration(s)
Registration Number9616936
FEI Number3002671736
NameAPEX BIOTECHNOLOGY CORP.
Owner & OperatorAPEX BIOTECHNOLOGY CORP.
Contact AddressNO. 7, LI-HSIN ROAD V, HSINCHU SCIENCE PARK
HSINCHU TW-NOTA 30078 TW
US Agent
Importing Logistics Registration
ImporterBrandon Kosaki
Address4 Drover Court, Trabuco Canyon
Coto de Caza, CA 92679 UNITED STATES
Email Addressb28@kebsite.com
Phone1 949 3544595
FAX1 253 5400611
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressNO. 7, LI-HSIN ROAD V, HSINCHU SCIENCE PARK
HSINCHU Hsinchu - District, 30078 TW
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Repack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
Apex Biotechnology Corp.
MultiSure GK Link Blood Glucose And Ketone Monitoring System2021-10-15
Apex BioTechnology Corp.
GlucoSure HT Plus Blood Glucose Monitoring System2021-09-15
APEX BIOTECHNOLOGY CORP.
THE EDGE Lactate Control Solution 2021-01-26
APEX BIOTECHNOLOGY CORP.
THE EDGE Blood Lactate Test Strip (non-sterile) 2021-01-26
APEX BIOTECHNOLOGY CORP.
THE EDGE Blood Lactate Monitoring System 2021-01-26
APEX BIOTECHNOLOGY CORP.
ApexBio SteriLance BLOOD LANCET (Sterile) 2020-05-25
APEX BIOTECHNOLOGY CORP.
UASure uric acid control solution 2020-05-19
APEX BIOTECHNOLOGY CORP.
UASure Blood Uric Acid Test Strip 2020-05-19
APEX BIOTECHNOLOGY CORP.
UASure Blood Uric Acid Monitoring Meter 2020-05-19
APEX BIOTECHNOLOGY CORP.
GLUCOCARD W Test Strips2019-04-08
APEX BIOTECHNOLOGY CORP.
KETOCOACH2018-12-19
Apex Biotechnology Corp.
KET-1 Blood Ketone Monitoring System2018-12-18
Apex Biotechnology Corp.
BGM014 Blood Glucose Monitoring System2018-11-28
APEX BIOTECHNOLOGY CORP.
UASure2017-06-28
APEX BIOTECHNOLOGY CORP.
UASure2017-06-27
APEX BIOTECHNOLOGY CORP.
Harmony2017-05-25
APEX BIOTECHNOLOGY CORP.
BGM0142017-05-25
APEX BIOTECHNOLOGY CORP.
Harmony2017-05-25
APEX BIOTECHNOLOGY CORP.
BGM0142017-05-25
APEX BIOTECHNOLOGY CORP.
Harmony2017-05-25
APEX BIOTECHNOLOGY CORP.
BGM0142017-05-25
APEX BIOTECHNOLOGY CORP.
BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System2016-12-23
APEX BIOTECHNOLOGY CORP.
Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips2015-10-14
Apex BioTechnology Corp.
GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System2015-08-06
APEX BIOTECHNOLOGY CORP.
BGM009 BLOOD GLUCOSE MONITORING SYSTEM2015-05-01
APEX BIOTECHNOLOGY CORP.
AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM2014-03-06
APEX BIOTECHNOLOGY CORP.
Assure Platinum Blood Glucose Monitoring System2014-01-06
APEX BIOTECHNOLOGY CORP.
Assure Platinum Blood Glucose Monitoring System2014-01-06
APEX BIOTECHNOLOGY CORP.
Assure Platinum Blood Glucose Monitoring System2014-01-06
APEX BIOTECHNOLOGY CORP.
TelCare2013-03-14
APEX BIOTECHNOLOGY CORP.
TelCare2013-03-14
APEX BIOTECHNOLOGY CORP.
TelCare2013-03-14
APEX BIOTECHNOLOGY CORP.
TelCare2013-03-14
APEX BIOTECHNOLOGY CORP.
AutoSure Voice 3 Plus2012-10-23
APEX BIOTECHNOLOGY CORP.
AutoSure Voice 3 Plus2012-10-23
APEX BIOTECHNOLOGY CORP.
MEG-2B2012-10-23
APEX BIOTECHNOLOGY CORP.
MEG-2B2012-10-23
APEX BIOTECHNOLOGY CORP.
MEG-2B2012-10-23
APEX BIOTECHNOLOGY CORP.
GAL-1E2012-10-23
APEX BIOTECHNOLOGY CORP.
GAL-1E2012-10-23
APEX BIOTECHNOLOGY CORP.
GAL-1A2012-10-23
APEX BIOTECHNOLOGY CORP.
Embrace EVO2012-10-23
APEX BIOTECHNOLOGY CORP.
GAL-1A2012-10-23
APEX BIOTECHNOLOGY CORP.
Embrace EVO2012-10-23
APEX BIOTECHNOLOGY CORP.
GlucoCard Expression2012-10-23
APEX BIOTECHNOLOGY CORP.
EvenCare G22012-10-23
APEX BIOTECHNOLOGY CORP.
Embrace Voice EVO2012-10-23
APEX BIOTECHNOLOGY CORP.
AutoSure Voice II Plus2012-10-23
APEX BIOTECHNOLOGY CORP.
Arriva2012-10-23
APEX BIOTECHNOLOGY CORP.
GlucoCard Expression2012-10-23
APEX BIOTECHNOLOGY CORP.
EvenCare G22012-10-23
APEX BIOTECHNOLOGY CORP.
Embrace Voice EVO2012-10-23
APEX BIOTECHNOLOGY CORP.
AutoSure Voice II Plus2012-10-23
APEX BIOTECHNOLOGY CORP.
Arriva2012-10-23
APEX BIOTECHNOLOGY CORP.
GlucoCard Expression2012-10-23
APEX BIOTECHNOLOGY CORP.
EvenCare G22012-10-23
APEX BIOTECHNOLOGY CORP.
Embrace Voice EVO2012-10-23
APEX BIOTECHNOLOGY CORP.
AutoSure Voice II Plus2012-10-23
APEX BIOTECHNOLOGY CORP.
Arriva2012-10-23
APEX BIOTECHNOLOGY CORP.
GAL-1C2012-10-23
APEX BIOTECHNOLOGY CORP.
GAL-1C2012-10-23
APEX BIOTECHNOLOGY CORP.
GAL-1C2012-10-23
APEX BIOTECHNOLOGY CORP.
MEG-22012-10-23
APEX BIOTECHNOLOGY CORP.
MEG-22012-10-23
APEX BIOTECHNOLOGY CORP.
MEG-22012-10-23
APEX BIOTECHNOLOGY CORP.
MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL2012-04-06
APEX BIOTECHNOLOGY CORP.
GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL2012-03-28
APEX BIOTECHNOLOGY CORP.
GAL-1A BLOOD GLUCOSE MONITORING SYSTEM2012-01-26
APEX BIOTECHNOLOGY CORP.
AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III2012-01-17
APEX BIOTECHNOLOGY CORP.
GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS2011-09-15
APEX BIOTECHNOLOGY CORP.
MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION2011-08-31
APEX BIOTECHNOLOGY CORP.
AutoSure Voice 3 Blood Glucose Monitoring System2011-06-02
APEX BIOTECHNOLOGY CORP.
AutoSure Voice 3 Blood Glucose Monitoring System2011-06-02
APEX BIOTECHNOLOGY CORP.
AutoSure Voice 3 Blood Glucose Monitoring System2011-06-02
APEX BIOTECHNOLOGY CORP.
AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP2011-04-28
APEX BIOTECHNOLOGY CORP.
AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM2010-11-18
APEX BIOTECHNOLOGY CORP.
AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM2010-11-18
APEX BIOTECHNOLOGY CORP.
AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS2010-08-13
APEX BIOTECHNOLOGY CORP.
Contrex Plus Low Control Solution2010-05-25
APEX BIOTECHNOLOGY CORP.
MODIFICATION TO EVENCARE BLOOD GLUC2009-10-19
APEX BIOTECHNOLOGY CORP.
MODIFICATION TO EVENCARE BLOOD GLUC2009-10-19
APEX BIOTECHNOLOGY CORP.
Embrace TALK2009-04-16
APEX BIOTECHNOLOGY CORP.
Embrace No Code BGMS2009-04-16
APEX BIOTECHNOLOGY CORP.
AutoSure Voice BGMS2009-04-16
APEX BIOTECHNOLOGY CORP.
Embrace TALK2009-04-16
APEX BIOTECHNOLOGY CORP.
Embrace No Code BGMS2009-04-16
APEX BIOTECHNOLOGY CORP.
AutoSure Voice BGMS2009-04-16
APEX BIOTECHNOLOGY CORP.
Embrace TALK2009-04-16
APEX BIOTECHNOLOGY CORP.
Embrace No Code BGMS2009-04-16
APEX BIOTECHNOLOGY CORP.
AutoSure Voice BGMS2009-04-16
APEX BIOTECHNOLOGY CORP.
GlucoSure Star Blood Glucose Monito2008-05-20
APEX BIOTECHNOLOGY CORP.
GlucoSure Star Blood Glucose Monito2008-05-20
APEX BIOTECHNOLOGY CORP.
GlucoSure Voice Blood Glucose Monit2008-05-20
APEX BIOTECHNOLOGY CORP.
Embrace Blood Glucose Monitoring Sy2008-05-20
APEX BIOTECHNOLOGY CORP.
Companion Blood Glucose Monitoring2008-05-20
APEX BIOTECHNOLOGY CORP.
BG Meter Eng/Fra Blood Glucose Moni2008-05-20
APEX BIOTECHNOLOGY CORP.
GlucoSure Voice Blood Glucose Monit2008-05-20
APEX BIOTECHNOLOGY CORP.
Embrace Blood Glucose Monitoring Sy2008-05-20
APEX BIOTECHNOLOGY CORP.
Companion Blood Glucose Monitoring2008-05-20
APEX BIOTECHNOLOGY CORP.
BG Meter Eng/Fra Blood Glucose Moni2008-05-20
APEX BIOTECHNOLOGY CORP.
GlucoSure Voice Blood Glucose Monit2008-05-20
APEX BIOTECHNOLOGY CORP.
Embrace Blood Glucose Monitoring Sy2008-05-20
APEX BIOTECHNOLOGY CORP.
Companion Blood Glucose Monitoring2008-05-20
APEX BIOTECHNOLOGY CORP.
BG Meter Eng/Fra Blood Glucose Moni2008-05-20
APEX BIOTECHNOLOGY CORP.
GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E12008-04-10
APEX BIOTECHNOLOGY CORP.
GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E12008-04-01
APEX BIOTECHNOLOGY CORP.
Assure 3 Glucose Control Solution2007-12-17
APEX BIOTECHNOLOGY CORP.
Assure 3 Glucose Control Solution2007-12-17
APEX BIOTECHNOLOGY CORP.
Modification to GlucoSure2007-11-30
APEX BIOTECHNOLOGY CORP.
GlucoSmart Blood Glucose Test Syste2007-11-19
APEX BIOTECHNOLOGY CORP.
GlucoSmart Blood Glucose Test Syste2007-11-19
APEX BIOTECHNOLOGY CORP.
Grace Mini Blood Glucose Test Syste2007-11-19
APEX BIOTECHNOLOGY CORP.
GlucoSure Blood Glucose Test System2007-11-19
APEX BIOTECHNOLOGY CORP.
EvenCare2007-11-19
APEX BIOTECHNOLOGY CORP.
Assure II2007-11-19
APEX BIOTECHNOLOGY CORP.
Assure 32007-11-19
APEX BIOTECHNOLOGY CORP.
Grace Mini Blood Glucose Test Syste2007-11-19
APEX BIOTECHNOLOGY CORP.
GlucoSure Blood Glucose Test System2007-11-19
APEX BIOTECHNOLOGY CORP.
EvenCare2007-11-19
APEX BIOTECHNOLOGY CORP.
Assure II2007-11-19
APEX BIOTECHNOLOGY CORP.
Assure 32007-11-19
APEX BIOTECHNOLOGY CORP.
THE EDGE2007-06-12
APEX BIOTECHNOLOGY CORP.
ASSURE 4 BLOOD GLUCOSE TEST SYSTEM2007-04-27
APEX BIOTECHNOLOGY CORP.
ASSURE 4 BLOOD GLUCOSE TEST SYSTEM2007-04-27
APEX BIOTECHNOLOGY CORP.
ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM2007-02-16
APEX BIOTECHNOLOGY CORP.
GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM2007-02-06
APEX BIOTECHNOLOGY CORP.
MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 2211002001-05-18
APEX BIOTECHNOLOGY CORP.
GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM2001-01-22
APEX BIOTECHNOLOGY CORP.
GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM2001-01-22
APEX BIOTECHNOLOGY CORP.
Perfect 2 Blood Glucose Test System1998-07-31
APEX BIOTECHNOLOGY CORP.
Odyssey Blood Glucose Monitoring Sy1998-07-31
APEX BIOTECHNOLOGY CORP.
GlucoTrack1998-07-31
APEX BIOTECHNOLOGY CORP.
GLUCOSURE STAR BLOOD1998-07-31
APEX BIOTECHNOLOGY CORP.
Perfect 2 Blood Glucose Test System1998-07-31
APEX BIOTECHNOLOGY CORP.
Odyssey Blood Glucose Monitoring Sy1998-07-31
APEX BIOTECHNOLOGY CORP.
GlucoTrack1998-07-31
APEX BIOTECHNOLOGY CORP.
GLUCOSURE STAR BLOOD1998-07-31
APEX BIOTECHNOLOGY CORP.
Perfect 2 Blood Glucose Test System1998-07-31
APEX BIOTECHNOLOGY CORP.
Odyssey Blood Glucose Monitoring Sy1998-07-31
APEX BIOTECHNOLOGY CORP.
GlucoTrack1998-07-31
APEX BIOTECHNOLOGY CORP.
GLUCOSURE STAR BLOOD1998-07-31

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092417799Kaohsiung,China (Taiwan) -> Savannah, GeorgiaCARTON KIT(STARTER) TEST STRIPS AMAZON BUNDLE LABEL BLOOD GLUCOSE MONITORING SYSTEM CONTROL SOLUTION2886 CTN
2020091815567Kaohsiung,China (Taiwan) -> Tacoma, WashingtonTEST STRIP, CONTROL SOLUTION, METER KIT606 CTN
2020091729191Kaohsiung,China (Taiwan) -> Tacoma, WashingtonTEST STRIP, CONTROL SOLUTION, METER KIT606 CTN
2020091146056Kaohsiung,China (Taiwan) -> Tacoma, WashingtonTEST STRIP, CONTROL SOLUTION, METER KIT606 CTN
2020082717674Kaohsiung,China (Taiwan) -> Savannah, GeorgiaCARTON TEST STRIPS CONTROL SOLUTION KIT(STARTER) BLOOD GLUCOSE MONITORING SYSTEM HS CODE1966 CTN
2020081147928Kaohsiung,China (Taiwan) -> Tacoma, WashingtonTEST STRIP, CONTROL SOLUTION, METER KIT1398 CTN
2020081147928Kaohsiung,China (Taiwan) -> Tacoma, WashingtonTEST STRIP, CONTROL SOLUTION, METER KIT1398 CTN
202007257295Pusan,South Korea -> Boston, MassachusettsBIOTEL CARE METER(TM0008) HTS CODE:9027.80.453 6 PALLETS = 267 CTNS SET TEMPERATURE : +15.0 C267 CTN
2020070839628Kaohsiung,China (Taiwan) -> Tacoma, WashingtonTEST STRIP, CONTROL SOLUTION, METER1159 CTN
2020070839628Kaohsiung,China (Taiwan) -> Tacoma, WashingtonTEST STRIP, CONTROL SOLUTION, METER KIT1159 CTN

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