Data / Medical devices / Taiwan / Microlife Corp.
Microlife Corp.: FDA-registered device maker in Taipei, Taiwan, 78 510(k) clearances
Microlife Corp. is registered with the FDA (registration 8020605) in Taipei, Taiwan. It lists 7 device types. The FDA files 78 510(k) clearances under its listings, the newest dated June 28, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8020605
- FEI number
- 3003079707
- Address
- 9F, 431, RuiGuang Road, NeiHu, Taipei, Taiwan, 11492
- Owner or operator
- MICROLIFE CORP. (8020605)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 5, 2007
- Registered through
- 2026
- Brand names listed
- Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4B
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Oxygen-Uptake | BZL | 2 | Specification developer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Device, Fertility Diagnostic, Proceptive | LHD | U | Manufacturer | accessdata.fda.gov |
| Flowmeter, Blood, Cardiovascular | DPW | 2 | Manufacturer | accessdata.fda.gov |
| Meter, Peak Flow, Spirometry | BZH | 2 | Manufacturer | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 28, 2023 | K230075 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| May 19, 2023 | K222979 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| February 3, 2023 | K222153 | Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR) | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| March 1, 2022 | K211776 | Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| November 4, 2021 | K211288 | Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| April 8, 2021 | K202729 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| July 23, 2020 | K200738 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| June 18, 2020 | K200297 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| February 13, 2020 | K191829 | Microlife Non-Contact Infrared Forehead Thermometer | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| July 16, 2019 | K183663 | Microlife Digital Infrared Ear Thermometer | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| July 10, 2019 | K190818 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| March 12, 2019 | K183469 | Microlife Digital Blood Pressure Monitor | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| April 18, 2018 | K172880 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| March 16, 2018 | K171937 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| October 13, 2017 | K172498 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| August 30, 2017 | K170467 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| July 20, 2017 | K170219 | Microlife Digital Infrared Ear Thermometer | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| December 5, 2016 | K161728 | Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 | FLL | Substantially Equivalent | Microfile Intellectual Property GmbH | accessdata.fda.gov |
| February 12, 2016 | K153077 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| December 16, 2015 | K153450 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| October 21, 2015 | K152770 | ProBP 2400 Digital Blood Pressure Device | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| September 2, 2015 | K151869 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH, Switzerland | accessdata.fda.gov |
| July 14, 2015 | K151330 | Microlife Wrist Watch Blood Pressure Monitor | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH, Switzerland | accessdata.fda.gov |
| August 22, 2014 | K141083 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| July 2, 2014 | K140572 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH, Switzerland | accessdata.fda.gov |
| June 6, 2013 | K131346 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| May 13, 2013 | K122013 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M) | DXN | Substantially Equivalent | Microlife Corp. | accessdata.fda.gov |
| August 2, 2012 | K120430 | MICROLIFE WRIST WATCH BLOOD PREEURE MONITOR, BP3MO1-3P | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| January 27, 2012 | K113141 | MICROLIFE DUAL MODE THERMOMETER,MODEL IFR1MJ1 | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| December 5, 2011 | K112845 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| July 13, 2011 | K111652 | MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| April 6, 2011 | K103680 | MICROLIFE DIGITAL UNDERARM THERMOMETER | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| August 27, 2010 | K100763 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP HOME N BP3MX1-4 | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| July 1, 2010 | K101512 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCHBP OFFICE TARGET (BP3MD1-4). | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| May 28, 2010 | K101275 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE AFIB (TWIN200 AFS). | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| May 17, 2010 | K100953 | MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1 | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| October 23, 2009 | K092456 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BS1-3C | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| June 10, 2009 | K091589 | MICROLIFE DIGITAL ELECTRONIC THERMOMETER, MODEL MT16K1 | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| May 13, 2009 | K091040 | MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1 | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| November 24, 2008 | K082881 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP O3 | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| October 29, 2008 | K082357 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODELWATCHBP OFFICE (TWIN200). | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| May 13, 2008 | K080337 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D | DXN | Substantially Equivalent | Microlife Corp. | accessdata.fda.gov |
| January 11, 2008 | K073198 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP HOME (BP3MX1-1) | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| December 20, 2007 | K073398 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100) | DXN | Substantially Equivalent | Microlife Corp. | accessdata.fda.gov |
| December 20, 2007 | K073397 | MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50) | DXN | Substantially Equivalent | Microlife Corp. | accessdata.fda.gov |
| September 11, 2007 | K070590 | MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT19S1R | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| December 6, 2006 | K062867 | MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JC1 | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| September 11, 2006 | K061471 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PC | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| June 29, 2006 | K061558 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BU1-4U | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| June 14, 2006 | K061403 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1-4U | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| June 9, 2006 | K060686 | MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP3AC1-1PC | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| May 11, 2005 | K051100 | MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| December 9, 2004 | K043110 | MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1 | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| July 21, 2004 | K041411 | MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP | DXN | Substantially Equivalent | Microlife Corp. | accessdata.fda.gov |
| June 10, 2004 | K040723 | MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE) | BZH | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| March 22, 2004 | K040002 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1 | DXN | Substantially Equivalent | Microlife Intellectual Property Gmb | accessdata.fda.gov |
| February 23, 2004 | K033820 | MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1 | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| January 15, 2004 | K034023 | MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1 | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| January 8, 2004 | K033818 | MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DC1/V971, IR1DG1/SKU4289, IR1DH1/SKU4290 | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| January 8, 2004 | K033817 | MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DA1-2, IR1DE1-2 | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| November 14, 2003 | K031024 | MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100 | BZH | Substantially Equivalent | Microlife Corp. | accessdata.fda.gov |
| September 23, 2003 | K032364 | MICROLIFE DIGITAL UNDERARM ELECTRONIC THERMOMETER, MODEL MT 18E1 (V932) | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| September 12, 2003 | K030961 | MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 | LHD | Substantially Equivalent | Microlife Corp. | accessdata.fda.gov |
| September 11, 2003 | K032658 | MICROLIFE MODEL MT18E1-1 (V932-1) DIGITAL UNDERARM ELECTRONIC THERMOMETER | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| August 15, 2003 | K031958 | MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JA1 | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| June 28, 2002 | K021305 | MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL PRINTER | DXN | Substantially Equivalent | Microlife Corp. | accessdata.fda.gov |
| June 14, 2002 | K021605 | MEDGEM | BZL | Substantially Equivalent | Healthetech, Inc. | accessdata.fda.gov |
| March 12, 2002 | K020725 | MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1 | FLL | Substantially Equivalent | Microlife Corp. | accessdata.fda.gov |
| January 17, 2002 | K013485 | MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH OPTIONAL THERMAL PRINTER, MODEL PR 1KA1 | DXN | Substantially Equivalent | Microlife Corp. | accessdata.fda.gov |
| January 10, 2002 | K010577 | BODYGEM, MODEL HB211 | BZL | Substantially Equivalent | Healthetech, Inc. | accessdata.fda.gov |
| November 14, 2000 | K003308 | MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD1 | FLL | Substantially Equivalent | Microlife Corp. | accessdata.fda.gov |
| August 22, 2000 | K000969 | MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1 | FLL | Substantially Equivalent | Microlife Corp. | accessdata.fda.gov |
| August 1, 2000 | K001182 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1 | DXN | Substantially Equivalent | Microlife Corp. | accessdata.fda.gov |
| February 25, 1999 | K990168 | MICROLIFE IT2CA1 | FLL | Substantially Equivalent | Microlife Systems AG | accessdata.fda.gov |
| April 30, 1998 | K970211 | MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR | DPW | Substantially Equivalent | Micro Weiss Electronics | accessdata.fda.gov |
| April 30, 1998 | K970139 | MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO | DPW | Substantially Equivalent | Micro Weiss Electronics | accessdata.fda.gov |
| July 10, 1997 | K972259 | PRO CHECK DIGITAL PACIFIER THERMOMETER | FLL | Substantially Equivalent | Micro Weiss Electronics | accessdata.fda.gov |
| May 23, 1985 | K851146 | DIGITAL THERMOMETER | FLL | Substantially Equivalent | Micro Idea Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Device, Fertility Diagnostic, Proceptive
- All makers of Meter, Peak Flow, Spirometry
- All makers of Computer, Oxygen-Uptake
- All makers of Pad, Heating, Powered
Updated June 28, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.