Bionime Corp

FDA Filings

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

TAIWANTAIWAN STOCK EXCHANGE4737DUNS 658637244
FDA Registration(s)
Registration Number3004183148
FEI Number3004183148
NameFeng-Yu Lee
Owner & OperatorBIONIME CORPORATION
Contact AddressNO. 100, Sec. 2, Daqing St. SOUTH DIST.
TAICHUNG CITY TW-NOTA 40242 TW
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address29122 Rancho Viejo Road, Suite 212
San Juan Capistrano, CA 92675 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
BIONIME CORPORATION
 GE 2024-10-29
BIONIME CORPORATION
 SMARTMETER 2024-01-26
BIONIME CORPORATION
 SMARTMETER 2023-12-25
BIONIME CORPORATION
 GE 2023-07-11
BIONIME CORPORATION
 RIGHTEST 2023-07-11
BIONIME CORPORATION
 ODM 99GS280D512020-01-27
BIONIME CORPORATION
 ODM 99GM280DR12020-01-27
BIONIME CORPORATION
 ODM 99GM282DR12020-01-27
BIONIME CORPORATION
 ODM 99GM291I012020-01-06
BIONIME CORPORATION
 RIGHTEST GT333 Control Solution 2019-10-16
BIONIME CORPORATION
 RIGHTEST GT333 Blood Glucose Test Strip 2019-10-16
BIONIME CORPORATION
 RIGHTEST GT333 Blood Glucose Test Strip 2019-10-16
BIONIME CORPORATION
 RIGHTEST GT333 Blood Glucose Test Strip 2019-10-16
BIONIME CORPORATION
 RIGHTEST GT333 Blood Glucose Monitoring System 2019-10-16
BIONIME CORPORATION
 RIGHTEST 2019-09-20
BIONIME CORPORATION
 RIGHTEST 2019-09-20
Feng-Yu Lee [BIONIME CORPORATION]
RIGHTEST Blood Glucose Monitoring System GM700SB2019-07-01
Feng-Yu Lee [BIONIME CORPORATION]
RIGHTEST Blood Glucose Monitoring System GM700S2019-07-01
Bionime Corporation
Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB2019-06-02
BIONIME CORPORATION
 GE 2019-04-02
BIONIME CORPORATION
 GE 2019-04-02
BIONIME CORPORATION
 GE 2018-12-03
BIONIME CORPORATION
 GE 2018-12-03
BIONIME CORPORATION
 GE 2018-12-03
BIONIME CORPORATION
 GE 2018-12-03
BIONIME CORPORATION
 GE 2018-12-03
BIONIME CORPORATION
 GE 2018-12-03
BIONIME CORPORATION
 GE 2018-12-03
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose Monitoring System Max2018-09-04
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose Monitoring System Max Plus2018-09-04
Feng-Yu Lee [BIONIME CORPORATION]
GE Blood Glucose Monitoring System Max2018-09-04
Feng-Yu Lee [BIONIME CORPORATION]
GE Blood Glucose Monitoring System Max Plus2018-09-04
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose Monitoring System Wiz2018-09-04
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose Monitoring System Wiz Plus2018-09-04
Feng-Yu Lee [BIONIME CORPORATION]
GE Blood Glucose Monitoring System Wiz2018-09-04
Feng-Yu Lee [BIONIME CORPORATION]
GE Blood Glucose Monitoring System Wiz Plus2018-09-04
Bionime Corporation
Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus2018-08-17
BIONIME CORPORATION
 GE 2018-07-06
BIONIME CORPORATION
 Rightest 2018-07-06
BIONIME CORPORATION
 Rightest 2018-07-06
BIONIME CORPORATION
 GE 2018-07-06
BIONIME CORPORATION
 GE 2018-07-06
BIONIME CORPORATION
 GE 2018-07-06
BIONIME CORPORATION
 GE 2018-07-06
BIONIME CORPORATION
 GE 2018-07-06
BIONIME CORPORATION
 GE 2018-07-06
BIONIME CORPORATION
 GE 2018-07-06
BIONIME CORPORATION
 GE 2018-07-06
BIONIME CORPORATION
 Rightest 2018-07-06
BIONIME CORPORATION
 Rightest 2018-07-06
BIONIME CORPORATION
 Rightest 2018-07-06
BIONIME CORPORATION
 Rightest 99GS3001152018-07-06
BIONIME CORPORATION
 GE 2018-07-06
BIONIME CORPORATION
 Rightest 2018-07-06
BIONIME CORPORATION
 Rightest 2018-07-06
BIONIME CORPORATION
 ODM 99GS291I512018-07-06
BIONIME CORPORATION
 Rightest 2018-07-06
BIONIME CORPORATION
 GE 2018-07-06
BIONIME CORPORATION
 GE 2018-07-06
BIONIME CORPORATION
 Rightest 2018-07-06
BIONIME CORPORATION
 GE 2018-07-06
BIONIME CORPORATION
 GE 2018-07-06
BIONIME CORPORATION
 Rightest 2018-07-06
BIONIME CORPORATION
 Rightest 2018-07-06
BIONIME CORPORATION
 Rightest 2018-07-06
Bionime Corporation
Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus2018-06-19
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose Monitoring System GM280B2017-07-09
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose Monitoring System GM2802017-07-09
Feng-Yu Lee [BIONIME CORPORATION]
GE Blood Glucose Monitoring System 1822017-07-09
Feng-Yu Lee [BIONIME CORPORATION]
GE Blood Glucose Monitoring System 1802017-07-09
Feng-Yu Lee [BIONIME CORPORATION]
Diathrive+ Bluetooth Blood Glucose Monitoring System2017-07-09
Feng-Yu Lee [BIONIME CORPORATION]
Diathrive+ Blood Glucose Monitoring System2017-07-09
Feng-Yu Lee [BIONIME CORPORATION]
iGlucose Blood Glucose Monitoring System2017-07-09
Feng-Yu Lee [BIONIME CORPORATION]
iGlucose Blood Glucose Monitoring System2017-07-09
Bionime Corporation
GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B,2017-07-06
BIONIME CORPORATION
IGlucose Blood Glucose Monitoring System2017-05-02
BIONIME CORPORATION
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM7202014-08-22
Feng-Yu Lee [BIONIME CORPORATION]
GE Diabetes Management System2014-05-05
Feng-Yu Lee [BIONIME CORPORATION]
GE Diabetes Management System2014-05-05
Feng-Yu Lee [BIONIME CORPORATION]
GE Diabetes Management System2014-05-05
Feng-Yu Lee [BIONIME CORPORATION]
GE Diabetes Management System2014-05-05
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Control Solution GC3102013-10-28
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Control Solution GC3002013-10-28
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Control Solution GC1102013-10-28
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Control Solution GC1002013-10-28
BIONIME CORPORATION
RIGHTEST CONTROL SOLUTION2013-10-24
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose Monitoring System GM7002013-01-29
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose Monitoring System GM6502013-01-29
Feng-Yu Lee [BIONIME CORPORATION]
GE300 Talking Blood Glucose Monitoring System2013-01-29
Feng-Yu Lee [BIONIME CORPORATION]
GE200 Blood Glucose Monitoring System2013-01-29
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose Monitoring System GM7002013-01-29
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose Monitoring System GM6502013-01-29
Feng-Yu Lee [BIONIME CORPORATION]
GE300 Talking Blood Glucose Monitoring System2013-01-29
Feng-Yu Lee [BIONIME CORPORATION]
GE200 Blood Glucose Monitoring System2013-01-29
BIONIME CORPORATION
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN2013-01-25
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose monitoring System GM6502012-08-15
Feng-Yu Lee [BIONIME CORPORATION]
GE GE300 Talking Blood Glucose Monitoring System2012-08-15
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose monitoring System GM6502012-08-15
Feng-Yu Lee [BIONIME CORPORATION]
GE GE300 Talking Blood Glucose Monitoring System2012-08-15
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose monitoring System GM6502012-08-15
Feng-Yu Lee [BIONIME CORPORATION]
GE GE300 Talking Blood Glucose Monitoring System2012-08-15
BIONIME CORPORATION
BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM6502012-08-03
Feng-Yu Lee [BIONIME CORPORATION]
GE Diabetes Management System2012-05-06
Feng-Yu Lee [BIONIME CORPORATION]
Bionime Diabetes Management System2012-05-06
Feng-Yu Lee [BIONIME CORPORATION]
GE Diabetes Management System2012-05-06
Feng-Yu Lee [BIONIME CORPORATION]
Bionime Diabetes Management System2012-05-06
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose Monitoring System GM7002012-04-18
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose Monitoring System GM7002012-04-18
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose Monitoring System GM7002012-04-18
BIONIME CORPORATION
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM7002012-03-29
BIONIME CORPORATION
BIONIME DIABETES MANAGEMENT SYSTEM VI.02012-02-27
Feng-Yu Lee [BIONIME CORPORATION]
Rightest GM250S Blood Glucose Monitoring System2010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Control Solution Wiz2010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Control Solution GC5502010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose Monitoring System, Model GM5502010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
PSS World Medical Quintet AC System2010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
Model GM250, Model GM2602010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
McKesson Quintet AC Test Strip2010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
McKesson Quintet AC Control Solution2010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
McKesson Quintet AC Blood Glucose Monitoring System Meter2010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
GE GE100 System2010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
GE 333 Control Solution2010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
Rightest GM250S Blood Glucose Monitoring System2010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Control Solution Wiz2010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Control Solution GC5502010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose Monitoring System, Model GM5502010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
PSS World Medical Quintet AC System2010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
Model GM250, Model GM2602010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
McKesson Quintet AC Test Strip2010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
McKesson Quintet AC Control Solution2010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
McKesson Quintet AC Blood Glucose Monitoring System Meter2010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
GE GE100 System2010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
GE 333 Control Solution2010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
Rightest GM250S Blood Glucose Monitoring System2010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Control Solution Wiz2010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Control Solution GC5502010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose Monitoring System, Model GM5502010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
PSS World Medical Quintet AC System2010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
Model GM250, Model GM2602010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
McKesson Quintet AC Test Strip2010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
McKesson Quintet AC Control Solution2010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
McKesson Quintet AC Blood Glucose Monitoring System Meter2010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
GE GE100 System2010-06-21
Feng-Yu Lee [BIONIME CORPORATION]
GE 333 Control Solution2010-06-21
BIONIME CORPORATION
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM5502010-06-18
Feng-Yu Lee [BIONIME CORPORATION]
System, Model GM1002008-09-24
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose Monitoring2008-09-24
Feng-Yu Lee [BIONIME CORPORATION]
System, Model GM1002008-09-24
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose Monitoring2008-09-24
BIONIME CORPORATION
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM1002008-09-18
Feng-Yu Lee [BIONIME CORPORATION]
System, Model GM1102008-09-18
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose Monitoring2008-09-18
Feng-Yu Lee [BIONIME CORPORATION]
System, Model GM1102008-09-18
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose Monitoring2008-09-18
BIONIME CORPORATION
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM1102008-09-11
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Lancing Device2008-08-12
Feng-Yu Lee [BIONIME CORPORATION]
GE Lancing Device2008-08-12
Feng-Yu Lee [BIONIME CORPORATION]
Bionime2008-08-12
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose Monitoring System, Model GM3102008-03-01
Feng-Yu Lee [BIONIME CORPORATION]
PSS World Medical QUINTET2008-03-01
Feng-Yu Lee [BIONIME CORPORATION]
Rightest Blood Glucose Monitoring System, Model GM3102008-03-01
Feng-Yu Lee [BIONIME CORPORATION]
PSS World Medical QUINTET2008-03-01
BIONIME CORPORATION
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM3102008-02-28
Feng-Yu Lee [BIONIME CORPORATION]
Bionime Rightest Blood Glucose Monitoring System2007-10-29
Feng-Yu Lee [BIONIME CORPORATION]
Bionime Rightest Blood Glucose Monitoring System2007-10-29
Feng-Yu Lee [BIONIME CORPORATION]
Monitoring System2007-10-29
Feng-Yu Lee [BIONIME CORPORATION]
Bionime Rightest Blood Glucose2007-10-29
Feng-Yu Lee [BIONIME CORPORATION]
Monitoring System2007-10-29
Feng-Yu Lee [BIONIME CORPORATION]
Bionime Rightest Blood Glucose2007-10-29
Feng-Yu Lee [BIONIME CORPORATION]
Glucose Monitoring System2007-10-29
Feng-Yu Lee [BIONIME CORPORATION]
Bionime Rightest Blood2007-10-29
Feng-Yu Lee [BIONIME CORPORATION]
Glucose Monitoring System2007-10-29
Feng-Yu Lee [BIONIME CORPORATION]
Bionime Rightest Blood2007-10-29
Feng-Yu Lee [BIONIME CORPORATION]
Glucose Monitoring System2007-10-29
Feng-Yu Lee [BIONIME CORPORATION]
Bionime Rightest Blood2007-10-29
BIONIME CORPORATION
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM2007-02-16
BIONIME CORPORATION
MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM2006-02-21
BIONIME CORPORATION
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM2005-01-03

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091548193Taipei,China (Taiwan) -> Los Angeles, CaliforniaMEDICAL SUPPLY(BLOOD GLUCOSE TEST STRIP)403 CTN
2020081245191Taipei,China (Taiwan) -> Los Angeles, CaliforniaMEDICAL SUPPLY(BLOOD GLUCOSE MONITORING SYSTE M-METER ONLY)413 CTN
2020080672288Taipei,China (Taiwan) -> Los Angeles, CaliforniaMEDICAL SUPPLY(BLOOD GLUCOSE MONITORING SYSTE M-METER ONLY)413 CTN
2020071437935Taipei,China (Taiwan) -> Los Angeles, CaliforniaMEDICAL SUPPLY-RIGHTEST BLOOD GLUCOSE MONITOR ING SYSTEM-METER243 CTN
2020062329596Kaohsiung,China (Taiwan) -> Tacoma, WashingtonGE200 BLOOD GLUCOSE MONITORING SYSTEM GE200 B .42 CTN
2020061948996Taipei,China (Taiwan) -> Los Angeles, CaliforniaMEDICAL SUPPLY(BLOOD GLUCOSE TEST STRIP)250 CTN
2020051652061Taipei,China (Taiwan) -> Los Angeles, CaliforniaMEDICAL SUPPLY(BLOOD GLUCOSE MONITORING SYSTE M-METER ONLY)477 CTN
2020042429019Taipei,China (Taiwan) -> Los Angeles, CaliforniaMEDICAL SUPPLY(GE BLOOD GLUCOSE MONITORING SY STEM)322 CTN
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