HomeChinaZhengzhou Fortune Bioscience Co., Ltd.

Zhengzhou Fortune Bioscience Co., Ltd.

China · 郑州 · www.fortunebio.com
✓ Record-verifiedregistrations found in 3 marketsUnified social credit code 9141012275515522X1

This company holds 38 NMPA certificates in China and has registrations in United Kingdom, Israel — 2 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
38China registrations
Class I 2Class II 31Class III 3
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
1registered device records
IVD 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
1registrations
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 Union1,033 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified
United States0 registration records, 0 510(k), 0 PMA, 10 excluded
China38 certificates (Class III 3 / II 31 / I 2), as of 2026-09-04
United Kingdom1 confirmed, 3 excluded
Brazil0 confirmed, 4 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada0 confirmed, 1 excluded

Regulatory identity

UK responsible person
Wellkang Ltd
Unified social credit code
9141012275515522X1
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
62
Annual revenue
RMB 10–30M
Website
www.fortunebio.com
Product categories
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
2003-10-10
Registered capital
CNY 20,000,000
Paid-in capital
CNY 20,000,000
Legal form
Limited liability company (wholly owned by a non-natural-person corporation)
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-04-03
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国械注准20193400615丙型肝炎病毒IgG抗体检测试剂盒(胶体金法)Class III
CN国械注准20183401891吗啡-甲基安非他明联合检测试剂盒(胶体金法)Class III
CN国械注准20183401890吗啡检测试剂盒(胶体金法)Class III
CN豫械注准20262400266载脂蛋白E4检测试剂盒(免疫层析法)Class II
UK33819One Step HCG Pregnancy Test (Colloidal Gold)IVD Devices for Self-Testing

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