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Sqi Diagnostics Systems, Inc.

Canada · Toronto

✓ 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

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

0registered imported devices

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

CACanadaMDALL

5active device licences

Class II 5

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

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: SQI DIAGNOSTICS SYSTEMS INC.

Business registration

Legal name: SQI DIAGNOSTICS SYSTEMS INC.
Corporation number: 4424531
Registration status: Inactive
Legal form: Canada Business Corporations Act
Incorporated: 2007-04-20
Registered address: 36 METEOR DR., TORONTO, ON, M9W 1A4

Business registration data from Corporations Canada, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K140691	IG_PLEX CELIAC DGP PANEL	2014-11-06
US	K102490	IGX PLEX CELIAC QUALITATIVE ASSAY	2011-06-02
US	K083080	IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM	2009-10-29
CA	78512	QUANTISPOT RHEUMATOID ARTHRITIS ASSAY	Class II
CA	78513	SQIDWORKS DIAGNOSTICS PLATFORM	Class II
CA	81016	IGX PLEX RHEUMATOID ARTHRITIS QUALITATIVE ASSAY	Class II

Sqi Diagnostics Systems, Inc.

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

Registration details (sample)

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