HomeChina湖南科方生物技术有限公司

湖南科方生物技术有限公司

China
✓ Record-verifiedregistrations found in 1 markets

This company holds 13 NMPA certificates in China.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
13China registrations
Class II 13
as of 2026-09-04
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
pendingnot queried
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
pendingnot queried
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
pendingnot queried
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
pendingnot queried
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.

China13 certificates (Class III 0 / II 13 / I 0), as of 2026-09-04

Company information

Country
China

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.

Registration details (sample)

MarketIdentifierNameClass / date
CN湘械注准20232400458脂蛋白相关磷脂酶A2(Lp-PLA2)测定试剂盒(荧光免疫层析法)Class II
CN湘械注准20232400457组织型纤溶酶原激活剂-抑制剂1复合体(t-PAIC)测定试剂盒(化学发光法)Class II
CN湘械注准20232400456脂联素测定试剂盒(胶乳增强免疫比浊法)Class II
CN湘械注准20232400455纤溶酶-α2纤溶酶抑制剂复合物(PIC)测定试剂盒(化学发光法)Class II

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