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.

TAIWAN

TAIWAN STOCK EXCHANGE

1733

DUNS 657608092

FDA Registration(s)

• Registration Number: 9616936
• FEI Number: 3002671736
• Name: APEX BIOTECHNOLOGY CORP.
• Owner & Operator: APEX BIOTECHNOLOGY CORP.
• Contact Address: NO. 7, LI-HSIN ROAD V, HSINCHU SCIENCE PARK; HSINCHU TW-NOTA 30078 TW
• US Agent:
  • TOMSPEIKERS
  • ARKRAY USA, INC.
  • 952 6463168
  • 952 6463110
  • speikerst@arkrayusa.com
• Importing Logistics Registration:
  • Importer: Brandon Kosaki
  • Address: 4 Drover Court, Trabuco Canyon ; Coto de Caza, CA 92679 UNITED STATES
  • Email Address: b28@kebsite.com
  • Phone: 1 949 3544595
  • FAX: 1 253 5400611
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: NO. 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	Device	Date
PMN K220421 Apex BioTechnology Corp.	BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System	2022-11-04
PMN K212140 Apex Biotechnology Corp.	GlucoSure Link Blood Glucose Monitoring System	2022-08-25
PMN K202534 Apex Biotechnology Corp.	MTM301 Blood Glucose And Ketone Monitoring System	2022-04-06
PMN K213887 Apex BioTechnology Corp.	GAL-1A Plus Blood Glucose Monitoring System	2022-03-29
GUDID 00886338000062 APEX BIOTECHNOLOGY CORP.	UASure II Blood Uric Acid Test Strips 25s S5640997	2022-01-04
GUDID 00886338000055 APEX BIOTECHNOLOGY CORP.	UASure II Uric Acid Control Solution L1 S5800397	2022-01-04
GUDID 00886338000031 APEX BIOTECHNOLOGY CORP.	UASure II Blood Uric Acid Monitoring System S95046	2022-01-04
PMN K201880 Apex Biotechnology Corp.	MultiSure GK Link Blood Glucose And Ketone Monitoring System	2021-10-15
PMN K202885 Apex BioTechnology Corp.	GlucoSure HT Plus Blood Glucose Monitoring System	2021-09-15
GUDID 04713648766554 APEX BIOTECHNOLOGY CORP.	THE EDGE Lactate Control Solution	2021-01-26
GUDID 04713648766547 APEX BIOTECHNOLOGY CORP.	THE EDGE Blood Lactate Test Strip (non-sterile)	2021-01-26
GUDID 04713648766530 APEX BIOTECHNOLOGY CORP.	THE EDGE Blood Lactate Monitoring System	2021-01-26
GUDID 04713648766493 APEX BIOTECHNOLOGY CORP.	ApexBio SteriLance BLOOD LANCET (Sterile)	2020-05-25
GUDID 04713648766486 APEX BIOTECHNOLOGY CORP.	UASure uric acid control solution	2020-05-19
GUDID 04713648766479 APEX BIOTECHNOLOGY CORP.	UASure Blood Uric Acid Test Strip	2020-05-19
GUDID 04713648766462 APEX BIOTECHNOLOGY CORP.	UASure Blood Uric Acid Monitoring Meter	2020-05-19
PMN K170064 | NBW APEX BIOTECHNOLOGY CORP.	GLUCOCARD W Test Strips	2019-04-08
PMN K182593 | JIN APEX BIOTECHNOLOGY CORP.	KETOCOACH	2018-12-19
PMN K182593 Apex Biotechnology Corp.	KET-1 Blood Ketone Monitoring System	2018-12-18
PMN K182992 Apex Biotechnology Corp.	BGM014 Blood Glucose Monitoring System	2018-11-28
JJX APEX BIOTECHNOLOGY CORP.	UASure	2017-06-28
LFQ APEX BIOTECHNOLOGY CORP.	UASure	2017-06-27
PMN K161299 | NBW APEX BIOTECHNOLOGY CORP.	Harmony	2017-05-25
PMN K161299 | NBW APEX BIOTECHNOLOGY CORP.	BGM014	2017-05-25
PMN K161299 | LFR APEX BIOTECHNOLOGY CORP.	Harmony	2017-05-25
PMN K161299 | LFR APEX BIOTECHNOLOGY CORP.	BGM014	2017-05-25
PMN K161299 | JJX APEX BIOTECHNOLOGY CORP.	Harmony	2017-05-25
PMN K161299 | JJX APEX BIOTECHNOLOGY CORP.	BGM014	2017-05-25
PMN K161299 APEX BIOTECHNOLOGY CORP.	BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System	2016-12-23
PMN K150396 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 Strips	2015-10-14
PMN K142689 Apex BioTechnology Corp.	GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System	2015-08-06
PMN K141036 APEX BIOTECHNOLOGY CORP.	BGM009 BLOOD GLUCOSE MONITORING SYSTEM	2015-05-01
PMN K131750 APEX BIOTECHNOLOGY CORP.	AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM	2014-03-06
PMN K092104 | NBW APEX BIOTECHNOLOGY CORP.	Assure Platinum Blood Glucose Monitoring System	2014-01-06
PMN K092104 | JJX APEX BIOTECHNOLOGY CORP.	Assure Platinum Blood Glucose Monitoring System	2014-01-06
PMN K092104 | CGA APEX BIOTECHNOLOGY CORP.	Assure Platinum Blood Glucose Monitoring System	2014-01-06
PMN K110571 | NBW APEX BIOTECHNOLOGY CORP.	TelCare	2013-03-14
PMN K110571 | JQP APEX BIOTECHNOLOGY CORP.	TelCare	2013-03-14
PMN K110571 | JJX APEX BIOTECHNOLOGY CORP.	TelCare	2013-03-14
PMN K110571 | CGA APEX BIOTECHNOLOGY CORP.	TelCare	2013-03-14
PMN K120649 | NBW APEX BIOTECHNOLOGY CORP.	AutoSure Voice 3 Plus	2012-10-23
PMN K120649 | CGA APEX BIOTECHNOLOGY CORP.	AutoSure Voice 3 Plus	2012-10-23
PMN K120448 | NBW APEX BIOTECHNOLOGY CORP.	MEG-2B	2012-10-23
PMN K120448 | JJX APEX BIOTECHNOLOGY CORP.	MEG-2B	2012-10-23
PMN K120448 | CGA APEX BIOTECHNOLOGY CORP.	MEG-2B	2012-10-23
PMN K113547 | NBW APEX BIOTECHNOLOGY CORP.	GAL-1E	2012-10-23
PMN K113547 | CGA APEX BIOTECHNOLOGY CORP.	GAL-1E	2012-10-23
PMN K113208 | NBW APEX BIOTECHNOLOGY CORP.	GAL-1A	2012-10-23
PMN K113208 | NBW APEX BIOTECHNOLOGY CORP.	Embrace EVO	2012-10-23
PMN K113208 | CGA APEX BIOTECHNOLOGY CORP.	GAL-1A	2012-10-23
PMN K113208 | CGA APEX BIOTECHNOLOGY CORP.	Embrace EVO	2012-10-23
PMN K113098 | NBW APEX BIOTECHNOLOGY CORP.	GlucoCard Expression	2012-10-23
PMN K113098 | NBW APEX BIOTECHNOLOGY CORP.	EvenCare G2	2012-10-23
PMN K113098 | NBW APEX BIOTECHNOLOGY CORP.	Embrace Voice EVO	2012-10-23
PMN K113098 | NBW APEX BIOTECHNOLOGY CORP.	AutoSure Voice II Plus	2012-10-23
PMN K113098 | NBW APEX BIOTECHNOLOGY CORP.	Arriva	2012-10-23
PMN K113098 | JJX APEX BIOTECHNOLOGY CORP.	GlucoCard Expression	2012-10-23
PMN K113098 | JJX APEX BIOTECHNOLOGY CORP.	EvenCare G2	2012-10-23
PMN K113098 | JJX APEX BIOTECHNOLOGY CORP.	Embrace Voice EVO	2012-10-23
PMN K113098 | JJX APEX BIOTECHNOLOGY CORP.	AutoSure Voice II Plus	2012-10-23
PMN K113098 | JJX APEX BIOTECHNOLOGY CORP.	Arriva	2012-10-23
PMN K113098 | CGA APEX BIOTECHNOLOGY CORP.	GlucoCard Expression	2012-10-23
PMN K113098 | CGA APEX BIOTECHNOLOGY CORP.	EvenCare G2	2012-10-23
PMN K113098 | CGA APEX BIOTECHNOLOGY CORP.	Embrace Voice EVO	2012-10-23
PMN K113098 | CGA APEX BIOTECHNOLOGY CORP.	AutoSure Voice II Plus	2012-10-23
PMN K113098 | CGA APEX BIOTECHNOLOGY CORP.	Arriva	2012-10-23
PMN K102816 | NBW APEX BIOTECHNOLOGY CORP.	GAL-1C	2012-10-23
PMN K102816 | JJX APEX BIOTECHNOLOGY CORP.	GAL-1C	2012-10-23
PMN K102816 | CGA APEX BIOTECHNOLOGY CORP.	GAL-1C	2012-10-23
PMN K101204 | NBW APEX BIOTECHNOLOGY CORP.	MEG-2	2012-10-23
PMN K101204 | JJX APEX BIOTECHNOLOGY CORP.	MEG-2	2012-10-23
PMN K101204 | CGA APEX BIOTECHNOLOGY CORP.	MEG-2	2012-10-23
PMN K120448 APEX BIOTECHNOLOGY CORP.	MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL	2012-04-06
PMN K113547 APEX BIOTECHNOLOGY CORP.	GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL	2012-03-28
PMN K113208 APEX BIOTECHNOLOGY CORP.	GAL-1A BLOOD GLUCOSE MONITORING SYSTEM	2012-01-26
PMN K113098 APEX BIOTECHNOLOGY CORP.	AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III	2012-01-17
PMN K102816 APEX BIOTECHNOLOGY CORP.	GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS	2011-09-15
PMN K101204 APEX BIOTECHNOLOGY CORP.	MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION	2011-08-31
PMN K102481 | NBW APEX BIOTECHNOLOGY CORP.	AutoSure Voice 3 Blood Glucose Monitoring System	2011-06-02
PMN K102481 | JJX APEX BIOTECHNOLOGY CORP.	AutoSure Voice 3 Blood Glucose Monitoring System	2011-06-02
PMN K102481 | CGA APEX BIOTECHNOLOGY CORP.	AutoSure Voice 3 Blood Glucose Monitoring System	2011-06-02
PMN K102481 APEX BIOTECHNOLOGY CORP.	AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP	2011-04-28
PMN K102037 | NBW APEX BIOTECHNOLOGY CORP.	AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM	2010-11-18
PMN K102037 | CGA APEX BIOTECHNOLOGY CORP.	AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM	2010-11-18
PMN K102037 APEX BIOTECHNOLOGY CORP.	AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS	2010-08-13
PMN K100747 | JJX APEX BIOTECHNOLOGY CORP.	Contrex Plus Low Control Solution	2010-05-25
PMN K031843 | NBW APEX BIOTECHNOLOGY CORP.	MODIFICATION TO EVENCARE BLOOD GLUC	2009-10-19
PMN K031843 | CGA APEX BIOTECHNOLOGY CORP.	MODIFICATION TO EVENCARE BLOOD GLUC	2009-10-19
PMN K090043 | NBW APEX BIOTECHNOLOGY CORP.	Embrace TALK	2009-04-16
PMN K090043 | NBW APEX BIOTECHNOLOGY CORP.	Embrace No Code BGMS	2009-04-16
PMN K090043 | NBW APEX BIOTECHNOLOGY CORP.	AutoSure Voice BGMS	2009-04-16
PMN K090043 | JJX APEX BIOTECHNOLOGY CORP.	Embrace TALK	2009-04-16
PMN K090043 | JJX APEX BIOTECHNOLOGY CORP.	Embrace No Code BGMS	2009-04-16
PMN K090043 | JJX APEX BIOTECHNOLOGY CORP.	AutoSure Voice BGMS	2009-04-16
PMN K090043 | CGA APEX BIOTECHNOLOGY CORP.	Embrace TALK	2009-04-16
PMN K090043 | CGA APEX BIOTECHNOLOGY CORP.	Embrace No Code BGMS	2009-04-16
PMN K090043 | CGA APEX BIOTECHNOLOGY CORP.	AutoSure Voice BGMS	2009-04-16
PMN K073648 | NBW APEX BIOTECHNOLOGY CORP.	GlucoSure Star Blood Glucose Monito	2008-05-20
PMN K073648 | CGA APEX BIOTECHNOLOGY CORP.	GlucoSure Star Blood Glucose Monito	2008-05-20
PMN K073137 | NBW APEX BIOTECHNOLOGY CORP.	GlucoSure Voice Blood Glucose Monit	2008-05-20
PMN K073137 | NBW APEX BIOTECHNOLOGY CORP.	Embrace Blood Glucose Monitoring Sy	2008-05-20
PMN K073137 | NBW APEX BIOTECHNOLOGY CORP.	Companion Blood Glucose Monitoring	2008-05-20
PMN K073137 | NBW APEX BIOTECHNOLOGY CORP.	BG Meter Eng/Fra Blood Glucose Moni	2008-05-20
PMN K073137 | JJX APEX BIOTECHNOLOGY CORP.	GlucoSure Voice Blood Glucose Monit	2008-05-20
PMN K073137 | JJX APEX BIOTECHNOLOGY CORP.	Embrace Blood Glucose Monitoring Sy	2008-05-20
PMN K073137 | JJX APEX BIOTECHNOLOGY CORP.	Companion Blood Glucose Monitoring	2008-05-20
PMN K073137 | JJX APEX BIOTECHNOLOGY CORP.	BG Meter Eng/Fra Blood Glucose Moni	2008-05-20
PMN K073137 | CGA APEX BIOTECHNOLOGY CORP.	GlucoSure Voice Blood Glucose Monit	2008-05-20
PMN K073137 | CGA APEX BIOTECHNOLOGY CORP.	Embrace Blood Glucose Monitoring Sy	2008-05-20
PMN K073137 | CGA APEX BIOTECHNOLOGY CORP.	Companion Blood Glucose Monitoring	2008-05-20
PMN K073137 | CGA APEX BIOTECHNOLOGY CORP.	BG Meter Eng/Fra Blood Glucose Moni	2008-05-20
PMN K073648 APEX BIOTECHNOLOGY CORP.	GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1	2008-04-10
PMN K073137 APEX BIOTECHNOLOGY CORP.	GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1	2008-04-01
PMN K002621 | NBW APEX BIOTECHNOLOGY CORP.	Assure 3 Glucose Control Solution	2007-12-17
PMN K002621 | CGA APEX BIOTECHNOLOGY CORP.	Assure 3 Glucose Control Solution	2007-12-17
PMN K011233 | CGA APEX BIOTECHNOLOGY CORP.	Modification to GlucoSure	2007-11-30
PMN K002624 | NBW APEX BIOTECHNOLOGY CORP.	GlucoSmart Blood Glucose Test Syste	2007-11-19
PMN K002624 | CGA APEX BIOTECHNOLOGY CORP.	GlucoSmart Blood Glucose Test Syste	2007-11-19
PMN K002621 | NBW APEX BIOTECHNOLOGY CORP.	Grace Mini Blood Glucose Test Syste	2007-11-19
PMN K002621 | NBW APEX BIOTECHNOLOGY CORP.	GlucoSure Blood Glucose Test System	2007-11-19
PMN K002621 | NBW APEX BIOTECHNOLOGY CORP.	EvenCare	2007-11-19
PMN K002621 | NBW APEX BIOTECHNOLOGY CORP.	Assure II	2007-11-19
PMN K002621 | NBW APEX BIOTECHNOLOGY CORP.	Assure 3	2007-11-19
PMN K002621 | CGA APEX BIOTECHNOLOGY CORP.	Grace Mini Blood Glucose Test Syste	2007-11-19
PMN K002621 | CGA APEX BIOTECHNOLOGY CORP.	GlucoSure Blood Glucose Test System	2007-11-19
PMN K002621 | CGA APEX BIOTECHNOLOGY CORP.	EvenCare	2007-11-19
PMN K002621 | CGA APEX BIOTECHNOLOGY CORP.	Assure II	2007-11-19
PMN K002621 | CGA APEX BIOTECHNOLOGY CORP.	Assure 3	2007-11-19
KHP APEX BIOTECHNOLOGY CORP.	THE EDGE	2007-06-12
PMN K070088 | NBW APEX BIOTECHNOLOGY CORP.	ASSURE 4 BLOOD GLUCOSE TEST SYSTEM	2007-04-27
PMN K070088 | CGA APEX BIOTECHNOLOGY CORP.	ASSURE 4 BLOOD GLUCOSE TEST SYSTEM	2007-04-27
PMN K070088 APEX BIOTECHNOLOGY CORP.	ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM	2007-02-16
PMN K062799 APEX BIOTECHNOLOGY CORP.	GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM	2007-02-06
PMN K011233 APEX BIOTECHNOLOGY CORP.	MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100	2001-05-18
PMN K002624 APEX BIOTECHNOLOGY CORP.	GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM	2001-01-22
PMN K002621 APEX BIOTECHNOLOGY CORP.	GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM	2001-01-22
PMN K062799 | NBW APEX BIOTECHNOLOGY CORP.	Perfect 2 Blood Glucose Test System	1998-07-31
PMN K062799 | NBW APEX BIOTECHNOLOGY CORP.	Odyssey Blood Glucose Monitoring Sy	1998-07-31
PMN K062799 | NBW APEX BIOTECHNOLOGY CORP.	GlucoTrack	1998-07-31
PMN K062799 | NBW APEX BIOTECHNOLOGY CORP.	GLUCOSURE STAR BLOOD	1998-07-31
PMN K062799 | JJX APEX BIOTECHNOLOGY CORP.	Perfect 2 Blood Glucose Test System	1998-07-31
PMN K062799 | JJX APEX BIOTECHNOLOGY CORP.	Odyssey Blood Glucose Monitoring Sy	1998-07-31
PMN K062799 | JJX APEX BIOTECHNOLOGY CORP.	GlucoTrack	1998-07-31
PMN K062799 | JJX APEX BIOTECHNOLOGY CORP.	GLUCOSURE STAR BLOOD	1998-07-31
PMN K062799 | CGA APEX BIOTECHNOLOGY CORP.	Perfect 2 Blood Glucose Test System	1998-07-31
PMN K062799 | CGA APEX BIOTECHNOLOGY CORP.	Odyssey Blood Glucose Monitoring Sy	1998-07-31
PMN K062799 | CGA APEX BIOTECHNOLOGY CORP.	GlucoTrack	1998-07-31
PMN K062799 | CGA APEX BIOTECHNOLOGY CORP.	GLUCOSURE STAR BLOOD	1998-07-31

Related Finance Registrations

NCAGE Code

SJCE4

Apex Biotechnology Corporation

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092417799	Kaohsiung,China (Taiwan) -> Savannah, Georgia	CARTON KIT(STARTER) TEST STRIPS AMAZON BUNDLE LABEL BLOOD GLUCOSE MONITORING SYSTEM CONTROL SOLUTION	2886 CTN
2020091815567	Kaohsiung,China (Taiwan) -> Tacoma, Washington	TEST STRIP, CONTROL SOLUTION, METER KIT	606 CTN
2020091729191	Kaohsiung,China (Taiwan) -> Tacoma, Washington	TEST STRIP, CONTROL SOLUTION, METER KIT	606 CTN
2020091146056	Kaohsiung,China (Taiwan) -> Tacoma, Washington	TEST STRIP, CONTROL SOLUTION, METER KIT	606 CTN
2020082717674	Kaohsiung,China (Taiwan) -> Savannah, Georgia	CARTON TEST STRIPS CONTROL SOLUTION KIT(STARTER) BLOOD GLUCOSE MONITORING SYSTEM HS CODE	1966 CTN
2020081147928	Kaohsiung,China (Taiwan) -> Tacoma, Washington	TEST STRIP, CONTROL SOLUTION, METER KIT	1398 CTN
2020081147928	Kaohsiung,China (Taiwan) -> Tacoma, Washington	TEST STRIP, CONTROL SOLUTION, METER KIT	1398 CTN
202007257295	Pusan,South Korea -> Boston, Massachusetts	BIOTEL CARE METER(TM0008) HTS CODE:9027.80.453 6 PALLETS = 267 CTNS SET TEMPERATURE : +15.0 C	267 CTN
2020070839628	Kaohsiung,China (Taiwan) -> Tacoma, Washington	TEST STRIP, CONTROL SOLUTION, METER	1159 CTN
2020070839628	Kaohsiung,China (Taiwan) -> Tacoma, Washington	TEST STRIP, CONTROL SOLUTION, METER KIT	1159 CTN