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GLOBAL INSTRUMENTATION CORP.

Taiwan · East Syracuse

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Australia — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

10listed device types

Class I 2Class II 8Class III 0

plus 8 registration records and 5 510(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

0active device licences

6 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIb 2

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 States8 registration records, 5 510(k), 0 PMA, 46 excluded

Brazil0 confirmed, 8 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada0 confirmed, 5 excluded

Manufacturer names merged into this page: GLOBAL INSTRUMENTATION CORP. · GLOBAL INSTRUMENTATION, LLC

FDA 510(k) clearances by year

12005 · K051730

12016 · K152701

12017 · K162463

12020 · K202456

12026 · K252840

FDA listed device types

showing 8 of 10

Single (Specified) Analyte Controls (Assayed And Unassayed) 1Nitroprusside, Ketones (Urinary, Non-Quant.) 1Detector And Alarm, Arrhythmia 1Glucose Oxidase, Glucose 1System, Measurement, Blood-Pressure, Non-Invasive 1Electrocardiograph, Ambulatory, With Analysis Algorithm 1Transmitters And Receivers, Electrocardiograph, Telephone 1System, Test, Blood Glucose, Over The Counter 1

Market	Identifier	Name	Class / date
US	K252840	M12 Telemetry System	2026-05-29
US	K202456	M5 Recorder	2020-12-29
US	K162463	Matrix Data Management System	2017-05-24

GLOBAL INSTRUMENTATION CORP.

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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