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BTNX Inc.

Canada · Pickering

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, 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

77listed device types

Class I 28Class II 46Class III 0unclassified 3

plus 73 registration records and 0 510(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

81active device licences

Class II 51Class III 30

180 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States73 registration records, 0 510(k), 0 PMA

Canada81 confirmed, 0 excluded

Manufacturer names merged into this page: BTNX Inc. · BTNX INC.

FDA listed device types

showing 8 of 77

Kit, Test, Pregnancy, Hcg, Over The Counter 1Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1Enzyme Immunoassay, Opiates 1Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt 1Enzyme Immunoassay, Benzodiazepine 1Devices Detecting Influenza A, B, And C Virus Antigens 1Thin Layer Chromatography, Methamphetamine 1Radioimmunoassay, Thyroid-Stimulating Hormone 1

Registration details (sample)

Market	Identifier	Name	Class / date
CA	65335	LH OVULATION TEST (URINE)	Class II
CA	70228	RAPID RESPONSE DRUGS OF ABUSE TESTING CASSETTES (URINE)	Class III
CA	70229	RAPID RESPONSE DRUGS OF ABUSE TESTING CARDS (URINE)	Class III

BTNX Inc.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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