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ARJ MEDICAL, LLC. / Gulf Coast Scientific, LLC.

USA · Tampa

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

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 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, Inc.. 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, LLC. / Gulf Coast Scientific, LLC.

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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