HomeChinaHipro Biotechnology Co., Ltd.

Hipro Biotechnology Co., Ltd.

China · 石家庄 · www.hipro.us
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000002171Unified social credit code 91130100794182204D

This company holds 65 NMPA certificates in China and has registrations in European Union, United States, Brazil — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
65China registrations
Class I 7Class II 58
as of 2026-09-04
EUEuropean UnionEUDAMED
2UDI-DI device records
IVD A 2
USUnited StatesFDA openFDA
22listed device types
Class I 17Class II 4Class III 0unclassified 1
plus 22 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
1 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
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 Union49 raw hits, 47 excluded, 2 confirmed
United States22 registration records, 1 510(k), 0 PMA
China65 certificates (Class III 0 / II 58 / I 7), as of 2026-09-04
United Kingdom0 confirmed, 1 excluded
Manufacturer names merged into this page: SHIJIAZHUANG HIPRO BIOTECHNOLOGY CO.,LTD · SHIJIAZHUANG HIPRO BIOTECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000002171
EU authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Unified social credit code
91130100794182204D
Exhibition record
CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
191
Annual revenue
under RMB 5M
Website
www.hipro.us
Product categories
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
2006-09-29
Registered capital
CNY 32,524,289
Paid-in capital
CNY 32,524,289
Legal form
Joint-stock limited company (unlisted)
Industry classification
Research and experimental development
Last approval date
2024-12-05
Recognitions
National High-Tech EnterpriseTechnology-based SMEGazelle enterpriseTechnology Innovation Demonstration 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.

FDA 510(k) clearances by year

12024 · K220999

FDA listed device types

showing 8 of 22
Antistreptolysin - Titer/Streptolysin O Reagent 1Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl 1Colorimeter, Photometer, Spectrophotometer For Clinical Use 1Radioimmunoassay, Follicle-Stimulating Hormone 1Fluorometric Method, Triglycerides 1Radioimmunoassay, Progesterone 1System, Test, Low Density, Lipoprotein 1Radioimmunoassay, Estradiol 1

Registration details (sample)

MarketIdentifierNameClass / date
CN冀械注准20242400349肌酐检测试剂盒(肌氨酸氧化酶法)Class II
CN冀械注准20242400348糖化血红蛋白检测试剂盒(干式免疫荧光法)Class II
CN冀械注准20222400397便隐血检测试剂盒(胶体金法)Class II
CN冀械注准20222400396便隐血/转铁蛋白联合检测试剂盒(胶体金法)Class II
EU06974071231059IVD A
EU06974071231011IVD A
USK220999Hipro Glycosylated Hemoglobin (HbA1c) Test System2024-09-12

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