LYSUN

What LYSUN does

Hangzhou Lysun Biotechnology Co., Ltd. (LYSUN) is a privately held Chinese in vitro diagnostic (IVD) manufacturer founded in 2018 and headquartered in Hangzhou Binjiang High-tech Zone. The company designs, produces, and sells point-of-care testing (POCT) instruments and the consumable reagents that accompany them, organized into a chronic-disease monitoring portfolio covering blood glucose, hemoglobin, blood lipid, uric acid, and renal function (creatinine, urea), plus a separate rapid diagnostic test line for infectious diseases, drugs of abuse, cardiac markers, women's health, tumor markers, and fecal occult blood. Core measurement technologies are electrochemical sensor methods (used in glucose and uric acid meters such as BGM-101, GUM-101) and reflectance photometry (used in lipid, hemoglobin, renal, and multi-function analyzers such as LPM-101, BHM-101, RFM-101, DBM-101, and the GULP-101/102 series, with the latter consolidating up to 11 parameters into one device). Colloidal gold immunochromatography underpins the rapid diagnostic test division.

LYSUN's commercial model combines three revenue streams: (1) direct hardware and reagent sales to consumers and clinical buyers via a 12-language website, WhatsApp, and email; (2) OEM/ODM private-label manufacturing for distributors and brands (with MOQs of 500 devices and 1,000 boxes of test strips); and (3) international distributor sales across 30+ countries in Europe, South Asia, and Southeast Asia. The company holds EN ISO 13485:2016, CE marking, NMPA registrations, and was awarded the first IVDR certificate for a blood lipid IVD product in March 2026, supporting its globalization thesis. The R&D team averages more than eight years of POCT product development experience, and the company holds 7 software copyrights, 4 invention patents, 1 utility model patent, and 3 appearance patents.

The company serves two primary customer segments: individual consumers managing chronic conditions (diabetes, hyperuricemia, dyslipidemia, anemia, chronic kidney disease) requiring at-home self-testing, and clinical facilities (hospitals, clinics, laboratories) needing POCT diagnostic equipment. Pricing is not publicly disclosed and operates on an inquiry-based B2B/B2C model with sample-evaluation programs. Headcount is 11–50 employees, no external funding rounds are disclosed, and revenue is not publicly reported.

Name

LYSUN

Legal name

Hangzhou Lysun Biotechnology Co., Ltd.

Website

https://lysunbio.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

11–50 employees

Short description

Hangzhou Lysun Biotechnology (LYSUN) is a privately held Chinese IVD manufacturer founded in 2018 that develops and sells point-of-care testing instruments and reagents for blood glucose, hemoglobin, lipid, uric acid, renal function, and rapid infectious-disease diagnostics, serving home self-testers and clinical facilities in 30+ countries.

Ownership category

akta.pro rank

Product category

Point-of-Care In Vitro Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM)

akta.pro secondary industries

Remote Diagnostics & Home Testing Devices (Connected POC/At-Home Diagnostic Readers) (HLAHACAL), Hematology & Coagulation Diagnostics (HLAHAAAB)

Keywords

• Point-of-care diagnostics
• In vitro diagnostics
• Blood glucose meters
• Rapid diagnostic tests
• Dry chemistry analyzers

Headquarters

HQ city

Hangzhou

HQ country

China

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Personnel, Technology or R&D, Operations, Marketing or Sales

Revenue model

1. IVD Reagent Sales: Sale of in vitro diagnostic reagents including blood glucose test strips, uric acid test strips, hemoglobin test strips, lipid test strips, renal function test strips, and rapid diagnostic tests
2. POCT Instrument Sales: Sale of supporting POCT instruments including blood glucose meters, hemoglobin meters, lipid analyzers, renal function meters, dry chemistry analyzers, and multi-function analyzers
3. OEM/ODM Services: Customization and private label manufacturing services for medical diagnostic devices with minimum order quantities of 500 devices and 1000 boxes of test strips

Pricing tiers

Go-to-market motion1 record

Distribution channels4 records

Marketing channels4 records

Core offering

LYSUN develops, manufactures, and sells in vitro diagnostic (IVD) reagents and supporting point-of-care testing (POCT) instruments, including blood glucose meters, hemoglobin analyzers, lipid analyzers, renal function meters, dry chemistry analyzers, multi-function analyzers, and a range of rapid diagnostic tests for infectious diseases, cardiac markers, drugs of abuse, and women's health. The company also provides OEM/ODM customization services for distributors and brand partners seeking to market private-label diagnostic devices.

Product overview

LYSUN (Hangzhou Lysun Biotechnology Co., Ltd) offers a comprehensive portfolio of in vitro diagnostic (IVD) point-of-care testing (POCT) products centered on dry chemistry and immunoassay platforms. The core product line includes: Blood Glucose Monitors (BGM-101/102/103) and compatible test strips (EGS-101); Multifunction Analyzers (GUM-101 for glucose/uric acid, GULP-101 4-in-1, GULP-102 11-in-1); Hemoglobin Analyzers (BHM-101/102/202) with test strips (BHS-101); Blood Lipid Analysis Meters (LPM-101/102) with cholesterol test strips (TCS-101, TGS-101, HLS-101); Renal Function Analyzers (RFM-101/202) for uric acid, creatinine, and urea; and the DBM-101 Dry Biochemical Analysis Meter capable of testing TC, TG, HDL, LDL, CR, UR, and UA parameters. The Rapid Diagnostic Test division covers infectious diseases (including COVID-19, Hepatitis, Dengue), drugs of abuse, cardiac markers, women's health (hCG, FSH, LH), tumor markers, and fecal occult blood. All products use either electrochemical sensor technology or reflectance photometry methodologies and are designed for both home self-testing and clinical/hospital use.

Differentiator

Problem solved

Functional benefit

Products and services

• BGM-101 Blood Glucose Meter Electrochemical blood glucose monitoring system for quantitative measurement of glucose in capillary or venous whole blood, with CE0123 certification for home and hospital use.
• GUM-101 Multifunction Analysis Meter (Glucose, Uric Acid) Dual-function electrochemical meter for quantitative measurement of glucose and uric acid using fresh capillary or venous whole blood samples.
• BHM-101 Hemoglobin Analysis Meter Reflectance photometer system for quantitative determination of hemoglobin (HB) and calculated hematocrit (HCT) in capillary and venous whole blood, with 800-record memory.
• LPM-101 Blood Lipid Analysis Meter Portable device for quantitative determination of Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL), Triglycerides (TG), with calculated TC/HDL ratio.
• RFM-101 Renal Function Analysis Meter Portable meter for quantitative determination of Uric Acid (UA), Creatinine (CR), and Urea (UR) in capillary blood, venous whole blood, plasma, and serum.
• DBM-101 Dry Biochemical Analysis Meter POCT dry biochemical analyzer for testing blood lipid (TC, TG, HDL, LDL) and renal function (CR, UR, UA), supporting up to 9 parameters with single or 3-in-1 test strips.
• GULP-101 4-in-1 Multi-function Analyzer 4-in-1 reflectance photometer measuring blood glucose, uric acid, blood lipid, and blood pressure with Bluetooth connectivity for data sync to phone or PC.
• GULP-102 11-in-1 Multi-function Analyzer Advanced multi-parameter analyzer monitoring blood glucose, hemoglobin, blood lipid, and renal function parameters in a single device.
• RFM-202 Creatinine Meter Portable creatinine-specific meter for quantitative determination of creatinine (CR) in capillary blood, venous whole blood, plasma, and serum with 500-record memory.
• COVID-19 Antigen Rapid Test Device (Colloidal Gold) Rapid visual immunoassay for qualitative detection of SARS-CoV-2 antigens from oropharyngeal and nasopharyngeal swab specimens with 15-minute results.
• Influenza A+B, COVID-19 and RSV Antigen Rapid Test Combo rapid test for simultaneous qualitative detection of Influenza A+B, COVID-19, and RSV virus antigens from nasal or saliva specimens.
• Hepatitis Rapid Test Series (HBsAg, HBeAg, HBcAb) Colloidal gold immunoassay rapid tests for qualitative detection of hepatitis B markers from blood samples.
• Drugs of Abuse Rapid Test Rapid immunoassay tests for qualitative detection of various drugs of abuse including morphine, methamphetamine, and other substances.
• Dengue NS1/IgG/IgM Rapid Test Colloidal gold rapid tests for qualitative detection of dengue NS1 antigens and IgG/IgM antibodies from blood samples.
• Cardiac Markers Rapid Test Rapid diagnostic tests for detection of cardiac marker biomarkers for acute coronary syndrome evaluation.
• Women's Health Rapid Test (hCG, FSH, LH) Rapid immunoassay tests for women's health including human chorionic gonadotropin (hCG) and follicle stimulating hormone (FSH) detection.
• Tumor Markers Rapid Test Rapid diagnostic tests for qualitative detection of tumor marker biomarkers for cancer screening applications.
• FOB (Fecal Occult Blood) Rapid Test Colloidal gold immunoassay for qualitative detection of hemoglobin in feces samples for gastrointestinal bleeding screening.
• COVID-19 Neutralizing Antibody Rapid Test Device (COV-301) Rapid test device for qualitative detection of COVID-19 neutralizing antibodies in blood samples.
• EGS-101 Blood Glucose Test Strips Electrochemical test strips for quantitative measurement of glucose in fresh capillary whole blood samples, compatible with BGM-101/102/103 meters.
• TCS-101 Total Cholesterol Test Strip Dry chemistry test strip for timed-endpoint measurement of Total Cholesterol (TC) in whole blood, serum, or plasma.
• BHS-101 Hemoglobin Test Strip Test strip for hemoglobin (HB) and hematocrit (HCT) measurement, compatible with BHM series hemoglobin analyzers.
• OEM/ODM Custom Manufacturing Services Private label and custom design manufacturing services for medical diagnostic devices, with minimum order quantities of 500 devices and 1,000 boxes of test strips.

Named customers1 record

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Two partnerships are on record, tiered minor and core.

• Hangzhou Liensheng Bio-Tech Co., Ltd.minorChannel Partner/ Reseller/ Distributor · 1 August 2025Distributor partnership for showcasing LYSUN medical devices at the Dhaka International Medical Exhibition in Bangladesh, representing LYSUN products in the South Asian market
• TÜV SÜDcoreStrategic or Co-development PartnerCertification partnership for EN ISO 13485:2016 quality management system certification and CE marking services for IVD products entering European markets

Scale indicators6 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• ACON Laboratories: US-headquartered IVD manufacturer offering blood glucose meters, rapid diagnostic tests, and OEM/ODM services for international distributors — directly comparable to LYSUN's portfolio and channels.
• EKF Diagnostics: UK-based point-of-care diagnostics company offering hemoglobin/hematology, HbA1c, and lactate analyzers — overlapping product lines with LYSUN's BHM hemoglobin meter and multi-function analyzers.
• i-SENS: Korean POCT company specializing in blood glucose and HbA1c monitoring systems with strong international OEM business — directly comparable electrochemical sensor product platform.
• SD Biosensor: Korean IVD maker with strong rapid diagnostic test (COVID, influenza, infectious disease) and POCT analyzer lines, competing head-to-head with LYSUN in colloidal gold immunochromatography.
• Sinocare Inc. China-based IVD and blood glucose monitoring manufacturer with overlapping electrochemical meter, multi-parameter analyzer, and test strip product lines targeting both home and clinical channels globally.
• OSANG Healthcare (Genexel-Sein): Korean manufacturer of blood glucose monitors and IVD reagents with global distribution and OEM capabilities — closely comparable technology stack and customer base to LYSUN.

Broad incumbents

• A. Menarini Diagnostics: European diagnostics division of the Menarini Group offering blood glucose meters (GlucoMen), HbA1c analyzers, and rapid tests — competes with LYSUN in EU POCT channels.
• Abbott Diabetes Care: Global incumbent (FreeStyle Libre, FreeStyle Optium) in blood glucose and continuous monitoring with massive brand presence; sets competitive pricing and technology benchmarks LYSUN must meet.
• Roche Diagnostics: Global IVD leader with cobas and Accu-Chek product lines spanning clinical chemistry and home glucose monitoring; broad incumbent whose portfolio overlaps LYSUN's chronic disease testing categories.
• YSI Life Sciences: Established US-based biochemistry analyzer provider with broader clinical and industrial footprint; overlaps with LYSUN's dry chemistry and multi-parameter analyzer offerings in clinical biochemistry.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/LysunLtd
• Facebookfacebook.com/profile.php
• LinkedInlinkedin.com/company/hangzhou-lysun-biotechnology-co-ltd

Compliance10 records

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about LYSUN