HomeChina苏州创澜生物科技有限公司

苏州创澜生物科技有限公司

China
✓ Record-verifiedregistrations found in 1 markets

This company holds 26 NMPA certificates in China.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
26China registrations
Class I 14Class II 1Class III 11
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.

China26 certificates (Class III 11 / II 1 / I 14), 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20253402447六项呼吸道病原菌核酸检测试剂盒(实时荧光PCR法)Class III
CN国械注准20253401540隐球菌荚膜多糖检测试剂盒(磁微粒化学发光法)Class III
CN国械注准20253401378念珠菌、阴道加德纳菌和阴道毛滴虫核酸检测试剂盒(实时荧光PCR法)Class III
CN国械注准20253400268结核分枝杆菌和利福平/异烟肼耐药突变检测试剂盒(实时荧光PCR法)Class III

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