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Agamatrix, Inc.

USA · Salem

✓ 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

4listed device types

Class I 1Class II 3Class III 0

plus 6 registration records and 14 510(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

2active device licences

Class III 2

9 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 States6 registration records, 14 510(k), 0 PMA

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: AGAMATRIX · AGAMATRIX, INC

FDA 510(k) clearances by year

22006

32007

12008

12009

12010

12011

22013

22016

12024

FDA listed device types

Glucose Oxidase, Glucose 1Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature 1System, Test, Blood Glucose, Over The Counter 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K241304	WaveSense Jazz Blood Glucose Monitoring System	2024-06-06
US	K161834	One Drop Blood Glucose Monitoring System	2016-11-30
US	K152365	AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System	2016-04-21
CA	70984	KEYNOTE BLOOD GLUCOSE MONITORING SYSTEM	Class III
CA	99548	ONE DROP BLOOD GLUCOSE MONITORING SYSTEM	Class III

Agamatrix, 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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