HomeChinaBlue Cross Bio-Medical Co., Ltd.

Blue Cross Bio-Medical Co., Ltd.

China · Beijing
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Singapore — 3 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
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class II 4
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
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 States0 registration records, 1 510(k), 0 PMA, 16 excluded
Brazil4 confirmed, 4 excluded
Manufacturer names merged into this page: BLUE CROSS BIO-MEDICAL BIOTECH (BEIJING) CO. LTD. · BLUE CROSS BIO-MEDICAL (BEIJING) CO., LTD

Company information

Country
China
City
Beijing

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

12007 · K071930

Registration details (sample)

MarketIdentifierNameClass / date
USK071930ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C2007-12-18
BR10369460008ONE STEP HCG URINE PREGNANCY TESTClass II
BR10369460105TESTE PARA DETECÇÃO DE GONADOTROFINA CORIONICA HUMANA BABY CHECKClass II
BR82016170011Fertil Time - Teste de Pico de Ovulação - LHClass II

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