Feng Yu Lee

FDA Filings

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

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

Registration Number3008534520
FEI Number3008534520
NameFeng-Yu Lee
Owner & OperatorBiodenta Corporation
Contact AddressNo.27, Danuan Rd., Tucheng Dist.,
New Taipei City 236, TW-TPQ Taipei - District 236 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 TypeManufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number3014375716
FEI Number3014375716
NameFeng-Yu Lee
Owner & OperatorSkyla Corporation Hsinchu Science Park Branch
Contact Address1F, No.8, Dusing Road, Hsinchu Science P
Hsinchu City TW-HSQ Hsinchu - District 30078 TW
Official Correspondent
  • Tina Hung
  • 886-3-6121288-5894
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address29122 Rancho Viejo Road, Suite 212
San Juan Capistrano, CA 92675 US
Establishment TypeManufacture Medical Device

Registration Number3008088588
FEI Number3008088588
NameFeng-Yu Lee
Owner & OperatorBiodenta Swiss AG
Contact AddressTramstrasse 16
Berneck CH-SG Sankt Gallen 9442 CH
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address29122 Rancho Viejo Road, Suite 212
San Juan Capistrano, CA 92675 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

Registration Number3011061417
FEI Number3011061417
NameFeng-Yu Lee
Owner & OperatoriXensor Co Ltd
Contact Address11492 6F., No.9, Aly. 2, Ln. 35, Jihu Rd Neihu Dist,
Taipei TW-TPQ Taipei - District 114 TW
Official Correspondent
  • PINTSUN CHAO
  • 886-2-87511335-203
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
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

Registration Number3015531743
FEI Number3015531743
NameFeng-Yu Lee
Owner & OperatorGMC Inc.
Contact AddressNo.686 Su Chu RD
Chuzhou CN-34 Anhui 239000 CN
Official Correspondent
  • Aden Tsao
  • 86-550-2172888-8868
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address29122 Rancho Viejo Road, Suite 212
San Juan Capistrano, CA 92675 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Feng-Yu Lee [iXensor Co Ltd]
PixoTest2019-11-11
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
Feng-Yu Lee [iXensor Co Ltd]
PixoTest2019-05-14
Feng-Yu Lee [iXensor Co Ltd]
PixoTest2019-05-14
Feng-Yu Lee [Biodenta Corporation]
Implant, Endosseous, Root-Form - Biodenta Dental Implant System - Bone Level Tapered D 3.0 and L 6.5 mm2019-02-19
Feng-Yu Lee [Skyla Corporation Hsinchu Science Park Branch]
skyla2019-02-01
Feng-Yu Lee [Skyla Corporation Hsinchu Science Park Branch]
skyla2019-02-01
Feng-Yu Lee [Skyla Corporation Hsinchu Science Park Branch]
skyla2019-02-01
Feng-Yu Lee [Skyla Corporation Hsinchu Science Park Branch]
skyla2019-02-01
Feng-Yu Lee [Skyla Corporation Hsinchu Science Park Branch]
skyla2019-02-01
Feng-Yu Lee [Skyla Corporation Hsinchu Science Park Branch]
skyla2019-02-01
Feng-Yu Lee [Skyla Corporation Hsinchu Science Park Branch]
skyla2019-02-01
Feng-Yu Lee [Skyla Corporation Hsinchu Science Park Branch]
skyla2019-02-01
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
Feng-Yu Lee [iXensor Co Ltd]
PixoTest2017-11-13
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
Feng-Yu Lee [iXensor Co Ltd]
PixoTest2017-02-02
Feng-Yu Lee [iXensor Co Ltd]
Eveline2017-02-02
Feng-Yu Lee [iXensor Co Ltd]
CVSHealth2017-02-02
Feng-Yu Lee [Biodenta Swiss AG]
Biodenta Dental Implant System - Surgical and Prosthetic Accessory2016-09-13
Feng-Yu Lee [Biodenta Swiss AG]
Biodenta / DentaSwiss Scanbody2016-09-13
Feng-Yu Lee [Biodenta Corporation]
Biodenta Dental Implant System - Surgical and Prosthetic Accessory2016-09-13
Feng-Yu Lee [Biodenta Corporation]
Biodenta / DentaSwiss Scanbody2016-09-13
Feng-Yu Lee [Biodenta Swiss AG]
Biodenta Customized Abutment - Titanium2015-12-22
Feng-Yu Lee [Biodenta Corporation]
Biodenta Customized Abutment - Titanium2015-12-22
Feng-Yu Lee [Biodenta Swiss AG]
Biodenta Customized Abutment - Hybrid2015-08-06
Feng-Yu Lee [Biodenta Corporation]
Biodenta Customized Abutment - Hybrid2015-08-06
Feng-Yu Lee [Biodenta Swiss AG]
Implant, Endosseous, Root-Form - Biodenta Dental Implant System - Bone Level Tapered D 3.0 and L 6.5 mm2014-07-16
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 [Biodenta Corporation]
BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM2013-12-17
Feng-Yu Lee [Biodenta Corporation]
BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM2013-12-17
Feng-Yu Lee [Biodenta Corporation]
BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT2013-12-17
Feng-Yu Lee [Biodenta Corporation]
BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED2013-12-17
Feng-Yu Lee [Biodenta Corporation]
BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS2013-12-17
Feng-Yu Lee [Biodenta Swiss AG]
Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm2013-12-03
Feng-Yu Lee [Biodenta Swiss AG]
Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm2013-12-03
Feng-Yu Lee [Biodenta Swiss AG]
Biodenta Dental Implant System - Multi-Use Abutment2013-12-03
Feng-Yu Lee [Biodenta Swiss AG]
Biodenta Dental Implant System - Abutments2013-12-03
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
Feng-Yu Lee [Biodenta Swiss AG]
Biodenta Dental Implant System (Bone Level Tapered)2013-05-22
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
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
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
Feng-Yu Lee [Biodenta Corporation]
Biodenta Dental Implant System (Bone Level)2011-10-17
Feng-Yu Lee [Biodenta Swiss AG]
Biodenta Dental Implant System (Bone Level)2011-09-21
Feng-Yu Lee [Biodenta Corporation]
Biodenta Dental Implant System2010-11-12
Feng-Yu Lee [Biodenta Swiss AG]
Biodenta Dental Implant System2010-08-23
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
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
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
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
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

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