HomeChinaHangzhou Bosure Biotech. Co., Ltd

Hangzhou Bosure Biotech. Co., Ltd

China · 杭州 · www.bosurebio.com.cn
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000003001Unified social credit code 913301020845510360

This company holds 7 NMPA certificates in China and has registrations in European Union, United Kingdom — 2 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
7China registrations
Class I 1Class II 6
as of 2026-09-04
EUEuropean UnionEUDAMED
26UDI-DI device records
IVD A 3IVD general 23
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
6registered device records
IVD general 6
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
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 Union26 raw hits, 0 excluded, 26 confirmed
China7 certificates (Class III 0 / II 6 / I 1), as of 2026-09-04
United Kingdom6 confirmed, 0 excluded

Regulatory identity

EU manufacturer SRN
CN-MF-000003001
EU authorised representative
JOYSUN GROUP S.L.U
UK responsible person
lotus global co ltd
Unified social credit code
913301020845510360
Exhibition record
CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
57
Annual revenue
under RMB 5M
Website
www.bosurebio.com.cn
Product categories
健康管理临床检验器械及试剂

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
2013-11-15
Registered capital
CNY 6,000,000
Paid-in capital
CNY 5,300,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Retail trade
Last approval date
2025-12-11
Recognitions
Micro and small enterpriseNational High-Tech Enterprise

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浙械注准20262400387血红蛋白质控品Class II
CN浙械注准20252221844血红蛋白分析仪Class II
CN浙械注准20242401168血红蛋白试纸条(干化学法)Class II
CN浙械注准20232221967血红蛋白分析仪Class II
EU06975519631493Hemoglobin Testing SystemIVD A
EU06975519630328Lipid Testing SystemIVD general
EU06975519631172Hemoglobin Testing SystemIVD general
EU06975519630052Hemoglobin Testing SystemIVD general
UK32435Hemoglobin Testing SystemIVD general
UK57272Hemoglobin Control SolutionIVD general
UK57273Hemoglobin Test StripsIVD general

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