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Beijing Strong Biotechnologies, Inc.

China · Beijing · en.bsbe.co.cn

✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000004362

This company has registrations in European Union, Brazil, Taiwan, South Korea, Israel — 5 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

3UDI-DI device records

IVD B 1IVD C 1IVD general 1

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

30registered devices

Class II 30

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

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

IVD import 2

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

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.

European Union5 raw hits, 2 excluded, 3 confirmed

United States0 registration records, 0 510(k), 0 PMA, 16 excluded

United Kingdom0 confirmed, 3 excluded

Brazil30 confirmed, 5 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: BEIJING STRONG BIOTECHNOLOGIES, INC. · BEIJING DIAGREAT BIOTECHNOLOGIES CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000004362
EU authorised representative: Lotus NL B.V.

Registration details (sample)

Market	Identifier	Name	Class / date
EU	16970301471018	—	IVD general
EU	06936736052454	BSBE	IVD B
EU	06936736067700	D-Dimer Assay Kit	IVD C
BR	80464810925	Família Total bile acid Assay Kit	Class II
BR	80464810866	Superoxide Dismutase Assay Kit (SOD) em família	Class II
BR	80464810867	Lipoprotein-associated Phospholipase A2 Assay Kit (Lp-PLA2) em família	Class II

Beijing Strong Biotechnologies, Inc.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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