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Home›China›Zhejiang Gene Science Co., Ltd.

Zhejiang Gene Science Co., Ltd.

China · Shaoxing Zhejiang
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
113listed device types
Class I 60Class II 46Class III 0unclassified 7
plus 120 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
45registered devices
Class I 5Class II 40
95 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.

United States120 registration records, 1 510(k), 0 PMA, 6 excluded
Brazil45 confirmed, 4 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: ZHEJIANG ORIENT GENE BIOTECH · ZHEJIANG GENE SCIENCE CO., LTD · ZHEJIANG ORIENT GENE BIOTECH CO., LTD. · ZHEJIANG ORIENT GENE BIOTECH CO, LTD.

Company information

Country
China
City
Shaoxing Zhejiang

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.

FDA 510(k) clearances by year

12024 · K212878

FDA listed device types

showing 8 of 113
Colorimeter, Photometer, Spectrophotometer For Clinical Use 1Test, Luteinizing Hormone (Lh), Over The Counter 1Container, Specimen, Sterile 1Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Test, Follicle Stimulating Hormone (Fsh), Over The Counter 1Immunohistochemistry Reagents And Kits 1Enzyme Immunoassay, Nicotine And Nicotine Metabolites 1

Registration details (sample)

MarketIdentifierNameClass / date
USK212878Sample preservation solution2024-04-08
BR82444370257Família LH Quantitative Test Kit (Time-Resolved FIA)Class II
BR82444370258Família IL-6 Quantitative Test Kit (Time-Resolved FIA)Class II
BR82444370260Família Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab)Class II

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