HomeChina天津博奥赛斯生物科技股份有限公司

天津博奥赛斯生物科技股份有限公司

China
✓ Record-verifiedregistrations found in 1 markets

This company holds 186 NMPA certificates in China.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
186China registrations
Class I 64Class II 90Class III 32
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.

China186 certificates (Class III 32 / II 90 / I 64), 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20253402093呼吸道合胞病毒抗原检测试剂盒(胶体金法)Class III
CN国械注准20253400441腺病毒抗原检测试剂盒(胶体金法)Class III
CN国械注准20253400194甲型/乙型流感病毒抗原检测试剂盒(胶体金法)Class III
CN国械注准20223400376总前列腺特异性抗原(tPSA)检测试剂盒(磁微粒化学发光法)Class III

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