HEALTH & LIFE CO., LTD.
合世生醫科技股份有限公司
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1996Founded
NT$474MPaid-in capital
0Plants
44Certifications
8Patents
NT$100–500MRevenue band
- Unified Business No.
- 97304042
- Industry
- Tobacco Manufacturing (1,186)
- Listing
- Listed (TPEx) (890) 1781
- Founded
- 1996-12-16
- Paid-in capital
- NT$ 474,076,050
- Phone
- 82271300
- Website
- https://www.healthandlife.com.tw/
- Exporter
- Yes — registered with the Trade Administration
- Annual revenue band
- NT$100–500M
- Ownership
- Family-run (inferred)
- North American market
- FCC equipment authorization FDA 510(k) clearance FDA medical device registration Health Canada medical device licence
- Representative tenure
- In office since at least 2013 (13+ years)
- Growth & profitability
- Revenue 2026-09 YoY +17.2%, year-to-date -3.5%
Gross margin 14.3%, operating margin -18%, net margin -12.4% (2026-Q2 YTD) - Compliance record
- FDA import refusal: 1 product(s), latest 2019-06-26
Certifications 44
- Medical device license (188)Official registry Valid until 2009-06-08 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2009-06-08 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2009-06-08 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2014-06-08 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2009-06-08 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2014-06-08 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2011-05-05 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2011-02-17 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2009-06-08 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2014-06-08 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2014-06-08 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2011-08-23 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2012-03-28 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2018-05-07 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2018-05-07 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2023-01-29 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2023-01-29 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2020-10-12 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2020-10-12 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2023-01-29 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2019-10-24 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2023-07-11 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2023-09-17 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2031-04-06 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2031-04-22 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2019-08-03 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2023-10-04 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2031-04-06 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2021-04-22 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2031-04-22 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2029-08-03 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2030-03-06 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2031-04-22 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2016-06-14 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2021-07-25 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2029-08-03 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2019-08-03 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2023-07-11 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2016-11-30 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2014-06-08 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2023-07-11 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2014-06-22 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2021-04-22 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2030-08-12 · Taiwan Food and Drug Administration (TFDA)
Patents 8
- 2025 Respiration cycle measurement method
- 2022 Arm sleeve
- 2022 Blood pressure measurement data processing method and blood pressure measuring device
North American market evidence 59
- FCC equipment authorization 2ABTA 2014-02-04
- FDA 510(k) clearance K211744 2021-11-24
Non-Contact Infrared Thermometer, model HL710H - FDA 510(k) clearance K211127 2021-09-08
Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM - FDA 510(k) clearance K200521 2020-06-12
Full Automatic(NIBP) Blood Pressure Monitor - FDA 510(k) clearance K190507 2019-09-16
Full Automatic (NIBP) Blood Pressure Monitor - FDA 510(k) clearance K190133 2019-06-13
Full Automatic (NIBP) Blood Pressure Monitor-HL158UB - FDA 510(k) clearance K190134 2019-05-20
Full Automatic (NIBP) Blood Pressure Monitor-HL158TB - FDA 510(k) clearance K180240 2018-10-17
Full Automatic(NIBP) Blood Pressure Monitor - FDA 510(k) clearance K162338 2016-09-21
Full Automatic (NIBP) Blood Pressure Monitor - FDA 510(k) clearance K160557 2016-07-06
Full Automatic (NIBP) Blood Pressure Monitor - FDA 510(k) clearance K160145 2016-03-13
Full Automatic (NIBP) Blood Pressure Monitor - FDA 510(k) clearance K153214 2016-01-07
Full Automatic (NIBP) Blood Pressure Monitor - FDA 510(k) clearance K150311 2015-08-18
Full Automatic (NIBP)Blood Pressure Monitor - FDA 510(k) clearance K142968 2014-12-19
Full Automatic (NIBP) Blood Pressure Monitor - FDA 510(k) clearance K130564 2013-06-19
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR - FDA 510(k) clearance K130563 2013-06-18
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR - FDA 510(k) clearance K131121 2013-05-29
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR - FDA 510(k) clearance K110074 2012-05-25
HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM - FDA 510(k) clearance K113239 2012-03-16
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF) - FDA 510(k) clearance K113238 2012-03-01
FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR - FDA 510(k) clearance K112320 2011-09-30
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR - FDA 510(k) clearance K093831 2010-03-25
FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT - FDA 510(k) clearance K093824 2010-02-16
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL158BT - FDA 510(k) clearance K093823 2010-01-22
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888V, FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868JM - FDA 510(k) clearance K092163 2009-11-16
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB - FDA 510(k) clearance K092161 2009-09-30
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF - FDA 510(k) clearance K060835 2006-04-21
HL888SF - FDA 510(k) clearance K060729 2006-04-12
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168FV - FDA 510(k) clearance K050711 2005-04-07
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168JT - FDA 510(k) clearance K050714 2005-04-07
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168GA, HL168GS - FDA 510(k) clearance K050587 2005-04-05
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KM, HL888DM - FDA 510(k) clearance K050491 2005-03-31
H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KA, HL888LF & HL888IF - FDA 510(k) clearance K050249 2005-03-30
HL168JP - FDA 510(k) clearance K043437 2005-01-12
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET - FDA 510(k) clearance K043186 2004-12-06
H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM - FDA 510(k) clearance K042853 2004-11-10
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL888CF, HL888GF AND HL888QA - FDA 510(k) clearance K042802 2004-10-26
H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168H, HL168J & HL168Q - FDA 510(k) clearance K042265 2004-08-31
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR MODEL# HL888 - FDA 510(k) clearance K032837 2003-10-10
HL888BM - FDA 510(k) clearance K032839 2003-10-10
HL888BA - FDA 510(k) clearance K033043 2003-10-10
MODIFICATION TO HL168 - FDA 510(k) clearance K032695 2003-10-02
HL888BF - FDA 510(k) clearance K032913 2003-10-02
HL888 AF - FDA 510(k) clearance K031695 2003-07-01
HL168R - FDA 510(k) clearance K031835 2003-07-01
HL888RA - FDA 510(k) clearance K030541 2003-04-24
HL888JF - FDA 510(k) clearance K030499 2003-04-17
HL888HM - FDA 510(k) clearance K030498 2003-04-11
HL888HA - FDA 510(k) clearance K023834 2003-01-14
HL888 - FDA 510(k) clearance K020766 2002-04-05
HL168F - FDA 510(k) clearance K014122 2002-01-16
HL168E - FDA 510(k) clearance K013033 2001-10-23
MODIFICATION TO: HL168W TOUCH SCREEN - FDA 510(k) clearance K012310 2001-08-22
MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR - FDA 510(k) clearance K002882 2000-10-13
HL168B - FDA 510(k) clearance K002750 2000-09-18
HL168T - FDA 510(k) clearance K990807 1999-12-03
HL148 & HL168 - FDA medical device registration 9616390 2005-11-03 – 2022-11-22
System, Measurement, Blood-Pressure, Non-Invasive; Nebulizer, Medicinal, Non-Ventilatory (Atomizer); Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter and more (4) - FDA import refusal 3012437421 2019-06-26
GLUCOSE DEHYDROGENASE, GLUCOSE - Health Canada medical device licence 118478
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