HomeChinaGenrui Biotech Inc.

Genrui Biotech Inc.

China · Shenzhen · www.genrui-bio.com
✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000017351Unified social credit code 91440300766350741W

This company holds 257 NMPA certificates in China and has registrations in European Union, United States, Brazil, South Korea, Australia, Russia — 6 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
257China registrations
Class I 25Class II 231Class III 1
as of 2026-09-04
EUEuropean UnionEUDAMED
235UDI-DI device records
IVD A 55IVD B 12IVD C 8IVD general 160
USUnited StatesFDA openFDA
4listed device types
Class I 4Class II 0Class III 0
plus 4 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
33registered devices
Class I 9Class II 24
37 including historic records
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
4GMP quality-system certificates
IVD import 4
AUAustraliaTGA ARTG
1active ARTG entries
IVD Class 3 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
8active registrations
Class 2a 5Class 2b 1Class 3 2
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 Union235 raw hits, 0 excluded, 235 confirmed
United States4 registration records, 0 510(k), 0 PMA
China257 certificates (Class III 1 / II 231 / I 25), as of 2026-09-04
Brazil33 confirmed, 0 excluded
Manufacturer names merged into this page: GENRUI BIOTECH INC · GENRUI BIOTECH INC.

Regulatory identity

EU manufacturer SRN
CN-MF-000017351
EU authorised representative
Medunion S.L.
Unified social credit code
91440300766350741W
Exhibition record
CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Shenzhen
Social-insurance enrolees
457
Annual revenue
over RMB 500M
Website
www.genrui-bio.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
2004-08-16
Registered capital
CNY 60,000,000
Paid-in capital
CNY 60,000,000
Legal form
Joint-stock limited company (unlisted)
Industry classification
Pharmaceutical manufacturing
Last approval date
2026-08-05
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseNational SRDI "Little Giant"SRDI SME

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.

FDA listed device types

Clinical Sample Concentrator 1Colorimeter, Photometer, Spectrophotometer For Clinical Use 1Nephelometer 1Fluorometer 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263400895七种肺癌相关抗体检测试剂盒(化学发光免疫分析法)Class III
CN粤械注准20252401266血细胞分析仪用质控物(光学法)Class II
CN粤械注准20252401060血细胞分析仪用质控物(阻抗法)Class II
CN粤械注准20252400776抗缪勒氏管激素(AMH)测定试剂盒(荧光免疫层析法)Class II
EU06950334825050High Sensitivity C-Reactive Protein (HS-CRP) Detection KitIVD general
EU06950334824374Immunoglobulin G3 (IgG3) Detection KitIVD general
EU06950334824367Immunoglobulin G2 (IgG2) Detection KitIVD general
EU06950334824350Immunoglobulin G1 (IgG1) Detection KitIVD general
BR80298970193Analisador Bioquímico Automático MAX BIO 200Class II
BR80298970202Analisador Bioquímico Automático MAX BIO 480Class II
BR80298970103FITAS PARA TESTE DE URINA MAX URO BA-11AClass II

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