HomeChinaHangzhou Lysun Biotechnology Co.,Ltd

Hangzhou Lysun Biotechnology Co.,Ltd

China · 杭州 · www.lysunbio.com ; www.lysun.com.cn
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000010254Unified social credit code 91330108MA2BOTJL2M

This company holds 10 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Israel — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
10China registrations
Class II 10
as of 2026-09-04
EUEuropean UnionEUDAMED
79UDI-DI device records
IVD A 15IVD general 62ivd-devices-self-testing 2
USUnited StatesFDA openFDA
22listed device types
Class I 8Class II 14Class III 0
plus 22 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
2registered device records
IVD general 1IVD Devices for Self-Testing 1
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union79 raw hits, 0 excluded, 79 confirmed
United States22 registration records, 0 510(k), 0 PMA
China10 certificates (Class III 0 / II 10 / I 0), as of 2026-09-04
United Kingdom2 confirmed, 0 excluded
Manufacturer names merged into this page: HANGZHOU LYSUN BIOTECHNOLOGY CO.LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000010254
EU authorised representative
RIOMAVIX SOCIEDAD LIMITADA
UK responsible person
lotus global co ltd
Unified social credit code
91330108MA2BOTJL2M
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
40
Annual revenue
RMB 100–500M
Website
www.lysunbio.com ; www.lysun.com.cn

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
2018-02-08
Registered capital
CNY 7,800,000
Paid-in capital
CNY 7,800,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2024-04-07
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMESRDI SMEFledgling enterpriseInnovative SME

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA listed device types

showing 8 of 22
Test, Methamphetamine, Employment And Insurance Testing, Exempt 1Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt 1Test, Methadone, Employment And Insurance Testing, Exempt 1Test, Morphine, Employment And Insurance Testing, Exempt 1Control, Fecal Occult Blood 1Test, Methaqualone, Employment And Insurance Testing, Exempt 1Test, Cannabinoid, Employment And Insurance Testing, Exempt 1Test, Propoxyphene, Employment And Insurance Testing, Exempt 1

Registration details (sample)

MarketIdentifierNameClass / date
CN浙械注准20242222118血糖尿酸血脂血压分析仪Class II
CN浙械注准20222400396血糖试纸(葡萄糖氧化酶法)Class II
CN浙械注准20222400226尿酸/肌酐/尿素测试卡(干化学法)Class II
CN浙械注准20222400047尿酸试纸(电化学法)Class II
EU06971771201344IVD general
EU06971771209302IVD general
EU06971771201146ivd-devices-self-testing
EU06971771209029ivd-devices-self-testing
UK32435Hemoglobin Analysis MeterIVD general
UK65850Blood Lipid Analysis MeterIVD Devices for Self-Testing

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