Hmd Biomedical Inc

FDA Filings

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

FDA Registration(s)
Registration Number3003902721
FEI Number3003902721
NameHMD BIOMEDICAL, INC.
Owner & OperatorHMD BIOMEDICAL, INC.
Contact AddressNo 181 Minsheng St --
Xinpu Township TW-HSZ Hsinchu - Municipality 305 TW
Official Correspondent
  • Axel - Lin
  • 886-3-5895000-6111
US Agent
Importing Logistics Registration
ImporterLOOR MEDICAL HEALTHCARE EQUIPMENT,INC.
Address358 Fenimore Ave
Uniondale, NY 11553 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressNo 181 Minsheng St, Xinpu Township
Hsinchu County Hsinchu - District, 305 TW
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
HMD BIOMEDICAL INC.
LPOW Blood Glucose Test Strip 3S-01-25003E2023-10-06
HMD BIOMEDICAL INC.
LPOW blood glucose monitoring system(Meter) 3K-01-25003E2023-10-06
HMD BIOMEDICAL INC.
Easy@Home Blood Glucose Test Strip 3S-01-2500382023-03-23
HMD BIOMEDICAL INC.
Easy@Home blood glucose monitoring system 3K-01-2500372023-03-23
HMD BIOMEDICAL INC.
GlucoLeader Enhance Blood Glucose Test Strip(for PTA) 3L-10-1200322021-01-15
HMD BIOMEDICAL INC.
GlucoLeader Enhance Blood Glucose foil packed test strip 3L-10-14003T2021-01-15
HMD BIOMEDICAL INC.
GoodLife foil packed test strip 3L-10-1600322021-01-15
HMD BIOMEDICAL INC.
GlucoLeader Enhance Blood Glucose vial packed test strip 3S-01-14003362021-01-13
HMD BIOMEDICAL INC.
GlucoLeader Enhance Blood Glucose Test Strip(for AF-SSA) 3S-01-14003332021-01-13
HMD BIOMEDICAL INC.
GlucoLeader Enhance Blood Glucose Monitoring System 3K-01-1400392021-01-13
HMD BIOMEDICAL INC.
GlucoLeader Enhance Blood Glucose Test Strip 3S-01-22X0342021-01-13
HMD BIOMEDICAL INC.
GlucoLeader Enhance Blood Glucose vial packed test strip 3S-01-14003Y2021-01-08
HMD BIOMEDICAL INC.
GlucoLeader Enhance Blood Glucose vial packed test strip 3S-01-1400352021-01-08
HMD BIOMEDICAL INC.
Renpho Blood Glucose vial packed test strip 2020-10-29
HMD BIOMEDICAL INC.
Renpho Blood Glucose Monitoring System 2020-10-29
HMD BIOMEDICAL INC.
metene Enhance Blood Glucose vial packed test strip 3S-01-2500352020-08-10
HMD BIOMEDICAL INC.
metene Enhance Blood Glucose Monitoring System 3K-01-2500342020-08-10
HMD BIOMEDICAL INC.
FIA Salut vial packed test strip(for SS) 3S-01-14003322020-07-30
HMD BIOMEDICAL INC.
FIA Salut vial packed test strip(for Elhenawy) 3S-01-1409962020-07-27
HMD BIOMEDICAL INC.
FIA Salut vial packed test strip(for SS) 3S-01-1400A12020-07-27
HMD BIOMEDICAL INC.
FIA Salut foil packed test strip(for SS) 3L-10-14003A2020-07-27
HMD BIOMEDICAL INC.
GlucoLeader Enhance Blood Glucose Test Strip 2020-07-17
HMD BIOMEDICAL INC.
GlucoLeader Enhance Blood Glucose Monitoring System 3K-01-1400362020-07-17
HMD BIOMEDICAL INC.
FIA Salut vial packed test strip 3S-01-1400A22020-07-16
HMD BIOMEDICAL INC.
FIA Salut foil packed test strip 3L-10-1400332020-07-16
HMD BIOMEDICAL INC.
FIA Salut vial packed test strip 3S-01-14003342020-07-16
HMD BIOMEDICAL INC.
PRECICHEK AutoCode vial packed test strip 3S-01-1600372020-07-14
HMD BIOMEDICAL INC.
PRECICHEK AutoCode vial packed test strip 3S-01-16003F2020-07-14
HMD BIOMEDICAL INC.
PRECICHEK AutoCode foil packed test strip 3L-10-16003G2020-07-14
HMD BIOMEDICAL INC.
PRECICHEK AutoCode foil packed test strip 3L-10-16003B2020-07-14
HMD BIOMEDICAL INC.
PRECICHEK AutoCode foil packed test strip 3L-10-16003D2020-07-14
HMD BIOMEDICAL INC.
PRECICHEK AutoCode AC302 3K-01-16003A2020-07-14
HMD BIOMEDICAL INC.
PRECICHEK AC300 3K-01-16003X2020-07-14
HMD BIOMEDICAL INC.
FIA Salut CS06 3K-01-14003162020-07-14
HMD BIOMEDICAL INC.
FIA Salut vial packed test strip 3S-01-14003352020-07-14
HMD BIOMEDICAL INC.
PRECICHEK AutoCode foil packed test strip 3L-10-1600312020-07-09
HMD BIOMEDICAL INC.
GlucoLeader Enhance Blood Glucose Test Strip(BR/BMT) 3S-01-14010J2020-05-19
HMD BIOMEDICAL INC.
GlucoLeader Enhance Blood Glucose Monitoring System(BR/IQ) 3K-01-1401082020-05-19
HMD BIOMEDICAL INC.
Rosie SmartMeter Professional Strip 3L-10-16003E2019-12-27
HMD BIOMEDICAL INC.
GL GoodLife Blood Glucose Test Strip 3S-01-16003E2019-12-27
HMD BIOMEDICAL INC.
Rosie SmartMeter Test Strips 50ct(vial) 3S-01-16003A2019-08-09
HMD BIOMEDICAL INC.
Rosie SmartMeter NFC Professional 3K-01-16003K2019-08-09
HMD BIOMEDICAL INC.
GL GoodLife AC300 Test Strip-Vial 3S-01-16003C2019-08-09
HMD BIOMEDICAL INC.
Rosie SmartMeter delete2019-08-09
HMD BIOMEDICAL INC.
Rosie SmartMeter 3K-01-16003H2019-08-09
HMD BIOMEDICAL, INC.
GlucoLeader Enhance Blood Glucose Monitoring System2019-05-15
HMD BioMedical Inc.
GlucoLeader Enhance Blood Glucose Monitoring System2019-05-08
HMD BIOMEDICAL INC.
GL GoodLife Blood Glucose Test Strip(CORP.) 3S-01-16003E2019-02-08
HMD BIOMEDICAL INC.
GL GoodLife AC-302 Blood Glucose Monitoring System(CORP.) 3K-01-16003R2019-02-08
HMD BIOMEDICAL INC.
GL GoodLife AC-302 Blood Glucose Monitoring System, Economy type(CORP.) 3K-01-16003N2019-02-08
HMD BIOMEDICAL INC.
GL GoodLife Glucose Control Solution(Level 1) 3C-01-8100322018-12-28
HMD BIOMEDICAL INC.
GL GoodLife Blood Glucose Test Strip-Foil For Cloudia 3L-10-8100372018-12-28
HMD BIOMEDICAL INC.
GL GoodLife AC11-Strip(foil) 3L-10-16003F2018-08-20
HMD BIOMEDICAL INC.
GL GoodLife 3K-01-16003G2018-07-06
HMD BIOMEDICAL INC.
Rosie SmartMeter Glucose Control Solutions 3C-01-1600332018-07-06
HMD BIOMEDICAL INC.
Rosie SmartMeter Professional Strip 3L-10-16003E2018-07-06
HMD BIOMEDICAL INC.
GL GoodLife Blood Glucose Meter AC-11 3K-01-16003S2018-07-06
HMD BIOMEDICAL INC.
GL GoodLife AC-302 Blood Glucose Monitoring System 3K-01-16003R2018-07-06
HMD BIOMEDICAL INC.
GL GoodLife Blood Glucose Monitoring System 3K-01-16003N2018-07-06
HMD BIOMEDICAL INC.
GL GoodLife Glucose Control Solutions 3C-01-1600322018-07-06
HMD BIOMEDICAL INC.
GL GoodLife 3K-01-8100372018-07-06
HMD BIOMEDICAL INC.
GL GoodLife Blood Glucose Test Strip AC (50 Strips&lancets in foil) 3L-10-16003A2018-07-06
HMD BIOMEDICAL INC.
GL GoodLife 3K-01-16003C2018-07-06
HMD BIOMEDICAL INC.
GL GoodLife Blood Glucose Test Strip AC (50ct in foil) 3K-01-16003C 2018-07-06
HMD BIOMEDICAL INC.
GL GoodLife Blood Glucose Test Strip 3S-01-16003E2018-07-06
HMD BIOMEDICAL, INC.
Rosie SmartMeter NFC Professional Blood Glucose Monitoring System2015-11-17
HMD BIOMEDICAL, INC.
GoodLife AC-301~AC-305 Blood Glucose Monitoring System2015-11-17
HMD BIOMEDICAL, INC.
GoodLife AC-300~AC-305 Professional Blood Glucose Monitoring System2015-11-17
HMD BIOMEDICAL, INC.
Rosie SmartMeter NFC Professional Blood Glucose Monitoring System2015-11-17
HMD BIOMEDICAL, INC.
GoodLife AC-301~AC-305 Blood Glucose Monitoring System2015-11-17
HMD BIOMEDICAL, INC.
GoodLife AC-300~AC-305 Professional Blood Glucose Monitoring System2015-11-17
HMD BIOMEDICAL, INC.
Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodli2015-05-14
HMD BIOMEDICAL, INC.
GL GoodLife Blood Glucose Monitoring System(Cloudia)2015-01-13
HMD BIOMEDICAL, INC.
FIA Blood Glucose Monitoring System(G2)2015-01-13
HMD BIOMEDICAL, INC.
GL GoodLife Blood Glucose Monitoring System(Cloudia)2015-01-13
HMD BIOMEDICAL, INC.
FIA Blood Glucose Monitoring System(G2)2015-01-13
HMD BIOMEDICAL, INC.
GL GoodLife Blood Glucose Monitoring System(Cloudia)2015-01-13
HMD BIOMEDICAL, INC.
FIA Blood Glucose Monitoring System(G2)2015-01-13
HMD BIOMEDICAL, INC.
FIA Blood Glucose Monitoring System (G2)2014-09-18
HMD BIOMEDICAL, INC.
Tianjin Huahong Lancet2014-09-18
HMD BIOMEDICAL, INC.
SteriLance Lancing Device2014-09-18
HMD BIOMEDICAL, INC.
SHANDONG LIANFA Lancing Devices2014-09-18
HMD BIOMEDICAL, INC.
Loris Safety Lancet2014-09-18
HMD BIOMEDICAL, INC.
GoodLife Lancing Device2014-09-18
HMD BIOMEDICAL, INC.
GoodLife Lancet2014-09-18
HMD BIOMEDICAL, INC.
GlucoLeader Safety Lancet2014-09-18
HMD BIOMEDICAL, INC.
GlucoLeader Lancing Device2014-09-18
HMD BIOMEDICAL, INC.
GlucoLeader Lancet2014-09-18
HMD BIOMEDICAL, INC.
GlucooLeader Software2014-06-27
HMD BIOMEDICAL, INC.
GoodLife CS-200 Professional Blood Glucose Monitoring System2013-02-19
HMD BIOMEDICAL, INC.
GoodLife CS-200 Blood Glucose Monitoring System2013-02-19
HMD BIOMEDICAL, INC.
FIA Biomed Salut Professional Blood Glucose Monitoring System2013-02-19
HMD BIOMEDICAL, INC.
FIA Biomed Salut Blood Glucose Monitoring System2013-02-19
HMD BIOMEDICAL, INC.
GoodLife CS-200 Professional Blood Glucose Monitoring System2013-02-19
HMD BIOMEDICAL, INC.
GoodLife CS-200 Blood Glucose Monitoring System2013-02-19
HMD BIOMEDICAL, INC.
FIA Biomed Salut Professional Blood Glucose Monitoring System2013-02-19
HMD BIOMEDICAL, INC.
FIA Biomed Salut Blood Glucose Monitoring System2013-02-19
HMD BIOMEDICAL, INC.
GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS2013-02-14
HMD BIOMEDICAL, INC.
PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System2012-11-13
HMD BIOMEDICAL, INC.
PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System2012-11-13
HMD BIOMEDICAL, INC.
PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM2012-11-09
HMD BIOMEDICAL, INC.
PRECICHEK Cloudia Blood Glucose Monitoring System2012-09-19
HMD BIOMEDICAL, INC.
PRECICHEK Cloudia Blood Glucose Monitoring System2012-09-19
HMD BIOMEDICAL, INC.
PRECICHEK Cloudia Blood Glucose Monitoring System2012-09-19
HMD BIOMEDICAL, INC.
TEST, BLOOD GLUCOSE SYSTEM2012-09-05
HMD BIOMEDICAL, INC.
Rosie SmartMeter Blood Glucose Monitoring System2012-08-01
HMD BIOMEDICAL, INC.
PRECICHEK AUTOCODE AC-300, AC-301, AC-302, AC-303, AC-304, and AC-305 blood glucose monitoring systems2012-08-01
HMD BIOMEDICAL, INC.
GoodLife AC-300~AC-305 Professional Blood Glucose Monitoring System2012-08-01
HMD BIOMEDICAL, INC.
GoodLife AC-300~AC-305 Blood Glucose Monitoring System2012-08-01
HMD BIOMEDICAL, INC.
Rosie SmartMeter Blood Glucose Monitoring System2012-08-01
HMD BIOMEDICAL, INC.
PRECICHEK AUTOCODE AC-300, AC-301, AC-302, AC-303, AC-304, and AC-305 blood glucose monitoring systems2012-08-01
HMD BIOMEDICAL, INC.
GoodLife AC-300~AC-305 Professional Blood Glucose Monitoring System2012-08-01
HMD BIOMEDICAL, INC.
GoodLife AC-300~AC-305 Blood Glucose Monitoring System2012-08-01
HMD BIOMEDICAL, INC.
Rosie SmartMeter Blood Glucose Monitoring System2012-08-01
HMD BIOMEDICAL, INC.
PRECICHEK AUTOCODE AC-300, AC-301, AC-302, AC-303, AC-304, and AC-305 blood glucose monitoring systems2012-08-01
HMD BIOMEDICAL, INC.
GoodLife AC-300~AC-305 Professional Blood Glucose Monitoring System2012-08-01
HMD BIOMEDICAL, INC.
GoodLife AC-300~AC-305 Blood Glucose Monitoring System2012-08-01
HMD BIOMEDICAL, INC.
GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM2012-07-27
HMD BIOMEDICAL, INC.
GlucoLeader Enhance Blood Glucose System2007-12-06
HMD BIOMEDICAL, INC.
GlucoLeader Enhance Blood Glucose System2007-12-06
HMD BIOMEDICAL, INC.
GlucoLeader Blood Glucose Test System2007-12-06
HMD BIOMEDICAL, INC.
GlucoLeader Blood Glucose Test System2007-12-06
HMD BIOMEDICAL, INC.
GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM2003-10-21
HMD BIOMEDICAL, INC.
GLUCOLEADER VALUE2003-08-04

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