HomeChinaShenzhen Zijian Biotechnology Co., Ltd.

Shenzhen Zijian Biotechnology Co., Ltd.

China · 深圳 · www.szzijian.com
✓ Record-verifiedregistrations found in 2 marketsEU SRN CN-MF-000022829Unified social credit code 91440300585615229B

This company holds 74 NMPA certificates in China and has registrations in European Union — 1 overseas markets. EU UDI-DI records ≥107, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
74China registrations
Class I 39Class II 32Class III 3
as of 2026-09-04
EUEuropean UnionEUDAMED
≥107UDI-DI device records
IVD A 28IVD general 79
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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 Union561 raw hits, 193 excluded, 107 confirmed. Large result set — only the first 300 verified
China74 certificates (Class III 3 / II 32 / I 39), as of 2026-09-04

Regulatory identity

EU manufacturer SRN
CN-MF-000022829
EU authorised representative
CMC Medical Devices & Drugs SL
Unified social credit code
91440300585615229B
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
0
Annual revenue
RMB 100–500M
Website
www.szzijian.com
Product categories
体外诊断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
2011-11-11
Registered capital
CNY 30,000,000
Paid-in capital
CNY 2,000,000
Legal form
Limited liability company
Industry classification
Leasing
Last approval date
2025-09-08
Recognitions
Micro and small enterpriseNational High-Tech Enterprise

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.

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263401027甲型/乙型流感病毒核酸检测试剂盒(荧光PCR法)Class III
CN国械注准20253402234肺炎支原体IgM抗体检测试剂盒(荧光免疫层析法)Class III
CN国械注准20253401908甲型/乙型流感病毒抗原检测试剂盒(荧光免疫层析法)Class III
CN粤械注准20252400827全程C反应蛋白/血清淀粉样蛋白A(CRP/SAA)测定试剂盒(荧光免疫层析法)Class II
EU06974674897058Testing packIVD A
EU06974674897041Testing packIVD A
EU06974674897034Testing packIVD A
EU06974674897027Testing packIVD A

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