HomeChinaBeijing Diagreat Biotechnologies Co., Ltd

Beijing Diagreat Biotechnologies Co., Ltd

China · Beijing · www.diagreat.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000019511Unified social credit code 911101120716743951

This company holds 245 NMPA certificates in China and has registrations in European Union, Brazil — 2 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
245China registrations
Class I 19Class II 226
as of 2026-09-04
EUEuropean UnionEUDAMED
282UDI-DI device records
IVD A 7IVD B 167IVD C 108
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
22registered devices
Class II 22
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 Union282 raw hits, 0 excluded, 282 confirmed
China245 certificates (Class III 0 / II 226 / I 19), as of 2026-09-04
Brazil22 confirmed, 0 excluded
Manufacturer names merged into this page: BEIJING DIAGREAT BIOTECHNOLOGIES CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000019511
EU authorised representative
MedNet EC-REP GmbH
Unified social credit code
911101120716743951
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Beijing
Social-insurance enrolees
113
Annual revenue
RMB 50–100M
Website
www.diagreat.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsClinical chemistry & immunoassays

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
2013-07-02
Registered capital
CNY 19,410,253
Paid-in capital
CNY 19,410,253
Legal form
Limited liability company
Industry classification
Pharmaceutical manufacturing
Last approval date
2026-05-09
Recognitions
National High-Tech EnterpriseSRDI SMEAbove-designated-size industrial 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京械注准20262400229癌抗原15-3测定试剂盒(化学发光免疫分析法)Class II
CN京械注准20252400215人附睾蛋白4测定试剂盒(化学发光免疫分析法)Class II
CN京械注准20252400214透明质酸测定试剂盒(化学发光免疫分析法)Class II
CN京械注准20252400213癌抗原125测定试剂盒(化学发光免疫分析法)Class II
EU06975182500195Procalcitonin Determination Kit (Fluorescence Immunochromatographic Assay)IVD C
EU06942293581238Anti-Cyclic Citrullinated Peptide Antibody Determination Kit (Fluorescence Immunochromatographic Assay)IVD B
EU06942293591046Tacrolimus CLIA Kit (Chemiluminescence Immunoassay)IVD C
EU06942293591107Chemiluminescent Wash SolutionIVD A
BR81086830057Time-Resolved Immunofluorescence Analyzer D 10Class II
BR81086830058Progesterone Determination KitClass II
BR8108683005925-hydroxy vitamin D Determination Kit (25-OHVD Determination Kit)Class II

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