HomeChina杭州迪安生物技术有限公司

杭州迪安生物技术有限公司

China
✓ Record-verifiedregistrations found in 1 markets

This company holds 577 NMPA certificates in China.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
577China registrations
Class I 564Class II 3Class III 10
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.

China577 certificates (Class III 10 / II 3 / I 564), 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国械注准20263401611结核分枝杆菌复合群核酸检测试剂盒(PCR-荧光探针法)Class III
CN国械注准20243401947人乳头瘤病毒基因分型检测试剂盒(PCR-反向点杂交法)Class III
CN国械注准20243401742人乳头瘤病毒核酸检测试剂盒(荧光PCR法)Class III
CN国械注准20233401454人类ALDH2基因多态性检测试剂盒(荧光PCR-熔解曲线法)Class III

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