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CTK BIOTECH, INC.

USA · San Diego

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Singapore, 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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

62listed device types

Class I 22Class II 32Class III 1unclassified 7

plus 62 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class II 5

33 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States62 registration records, 0 510(k), 0 PMA

Brazil5 confirmed, 0 excluded

Manufacturer names merged into this page: CTK BIOTECH, INC.

FDA listed device types

showing 8 of 62

Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies 1Reagents, 2019-Novel Coronavirus Nucleic Acid 1Test, Syphilis, Treponemal 1Reagent, Coronavirus Serological 1Reagents, Zika Virus Nucleic Acid 1Coronavirus Antigen Detection Test System. 1Zika Virus Serological Reagents (Emergency Use) 1Hepatitis A Test (Antibody And Igm Antibody) 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80524900043	TESTE RAPIDO ONSITE H. PYLORI Ag	Class II
BR	80524900057	TESTE RÁPIDO ONSITE ROTA-ADENO Ag	Class II
BR	80524900047	TESTE RÁPIDO ONSITE HSV-1 IgG/IgM	Class II

CTK BIOTECH, INC.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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