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Arj Medical, Inc.

USA · Tampa

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Singapore, South Korea, Australia, Israel — 6 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

2listed device types

Class I 1Class II 0Class III 1

plus 2 registration records and 3 510(k), 7 PMA

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

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

1active ARTG entries

IVD Class 2 1

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 States2 registration records, 3 510(k), 7 PMA

Manufacturer names merged into this page: ARJ MEDICAL, LLC. / Gulf Coast Scientific, LLC. · ARJ MEDICAL, INC

Same-named companies — This database also contains companies with near-identical names: ARJ MEDICAL, LLC. / Gulf Coast Scientific, LLC.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

22006 · K052719

12010 · K091472

FDA listed device types

Helicobacter Pylori 1Test, Urea Adult And Pediatric (Breath), 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K091472	URITEST 50 AND URITEST 500 URINE ANALYZER	2010-04-27
US	K052719	URITEST 10 URINALYSIS REAGENT STRIPS	2006-12-05
US	K052708	PYLO-PLUS	2006-05-01

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Arj Medical, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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