HomeChinaLansion Biotechnology Co., Ltd.

Lansion Biotechnology Co., Ltd.

China · 南京 · WWW.lansionbio.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000001086Unified social credit code 91320115MA1MXCYR9K

This company holds 139 NMPA certificates in China and has registrations in European Union, United Kingdom, Brazil — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
139China registrations
Class I 10Class II 129
as of 2026-09-04
EUEuropean UnionEUDAMED
52UDI-DI device records
IVD A 5IVD general 47
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
13registered device records
IVD general 13
BRBrazilANVISA
15registered devices
Class II 15
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
pendingnot queried
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 Union52 raw hits, 0 excluded, 52 confirmed
China139 certificates (Class III 0 / II 129 / I 10), as of 2026-09-04
United Kingdom13 confirmed, 0 excluded
Brazil15 confirmed, 0 excluded
Manufacturer names merged into this page: LANSION BIOTECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000001086
EU authorised representative
JOYSUN GROUP S.L.U
UK responsible person
Obelis UK Ltd
Unified social credit code
91320115MA1MXCYR9K
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
130
Annual revenue
over RMB 500M
Website
WWW.lansionbio.com
Product categories
临床检验器械及试剂体外诊断

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
2016-10-19
Registered capital
CNY 2,813,288
Paid-in capital
CNY 2,813,288
Legal form
Limited liability company
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-10-14
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMEPrivate technology enterpriseInnovative SME

Business registration data from Tianyancha, as of 2026-09-03. 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.

Registration details (sample)

MarketIdentifierNameClass / date
CN苏械注准20252400943血清淀粉样蛋白A/全量程C反应蛋白测定试剂盒(干式荧光免疫层析法)Class II
CN苏械注准20252221879干式荧光免疫分析仪Class II
CN苏械注准20252221851手持式凝血分析仪Class II
CN苏械注准20252221016手持式干式荧光免疫分析仪Class II
EU06975388110037IVD general
EU06975388110020IVD general
EU06975388116374IVD general
EU06975388110013IVD general
UK54607PSA Test Kit (Dry Fluorescence Immunoassay)IVD general
UK58769Ferritin Test Kit (Dry Fluorescence Immunoassay)IVD general
UK56706LS-1100 Dry Fluorescence Immunoassay AnalyzerIVD general
BR81327670135LS – HbA1c TESTClass II
BR81327670136LS – T4 TESTClass II
BR81327670138LS – ß-HCG TESTClass II

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