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Home›China›BD Rapid Diagnostics (Suzhou) Co. Ltd.

BD Rapid Diagnostics (Suzhou) Co. Ltd.

China · China (Jiangsu) Pilot Free Trade Zone Suzhou Area
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, South Korea — 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
6listed device types
Class I 3Class II 2Class III 0unclassified 1
plus 24 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
4valid device licences
Class I 3Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
IVD import 1
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 States24 registration records, 4 510(k), 0 PMA, 30 excluded
Brazil0 confirmed, 7 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada0 confirmed, 7 excluded
Manufacturer names merged into this page: BD Rapid Diagnostics (Suzhou) Co. Ltd.
Same-named companies — This database also contains companies with near-identical names: Bd Diagnostics. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
China (Jiangsu) Pilot Free Trade Zone Suzhou Area

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

11998 · K981770
12001 · K003809
12002 · K020716
12004 · K033566

FDA listed device types

Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings 1Devices Detecting Influenza A, B, And C Virus Antigens 1Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Antigens, All Groups, Streptococcus Spp. 1Covid-19 Multi-Analyte Antigen Device 1

Registration details (sample)

MarketIdentifierNameClass / date
USK033566MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-70622004-05-17
USK020716RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)2002-05-06
USK003809RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS2001-04-20

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