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Gammex, Inc.

USA · Middleton

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Saudi Arabia, Australia, Israel, Russia — 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

3510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

8registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

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 States0 registration records, 3 510(k), 0 PMA

Saudi Arabia8 confirmed, 0 excluded

Manufacturer names merged into this page: Gammex Inc

Registration details (sample)

Market	Identifier	Name	Class / date
US	K152303	CT Sim Laser System	2015-09-11
US	K954564	PID-1 PRECISION INTELLIGENT DOSIMETER	1996-04-22
US	K953514	COURIER II	1995-10-07
SA	ME0000010230SFDAA00012	Mammo 156 Phantom	—
SA	ME0000010230SFDAA00004	CT ACR 464 Phantom	—

Gammex, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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