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ABBOTT POINT OF CARE CANADA LIMITED

Canada · Ottawa Ontario

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, South Korea — 4 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

25listed device types

Class I 6Class II 19Class III 0

plus 66 registration records and 22 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class II 8

23 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

1active device licences

Class III 1

9 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

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 States66 registration records, 22 510(k), 0 PMA, 27 excluded

Brazil8 confirmed, 3 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada1 confirmed, 2 excluded

Manufacturer names merged into this page: ABBOTT POINT OF CARE INC. · ABBOTT POINT OF CARE CANADA LIMITED · ABBOTT POINT OF CARE INC

Business registration

Legal name: 2 THE POINT CANADA LIMITED
Corporation number: 11486942
Registration status: Inactive
Legal form: Canada Business Corporations Act
Incorporated: 2019-06-27
Registered address: 3842 Henrietta Way, Mississauga, Toronto, ON, L5M 7Y4

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

FDA 510(k) clearances by year

12011

12015

12016

12017

62020

12021

62023

12024

22025

22026

FDA listed device types

showing 8 of 25

Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph 1Electrode, Ion-Specific, Chloride 1Electrode, Ion Specific, Urea Nitrogen 1Test, Natriuretic Peptide 1Control, Hematocrit 1Ph Rate Measurement, Carbon-Dioxide 1Biosensor, Immunoassay, Cpk Or Isoenzymes 1Device, Hematocrit Measuring 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261039	i-STAT Crea cartridge with the i-STAT 1 System	2026-06-26
US	K253051	i-STAT hs-TnI cartridge with the i-STAT Alinity System	2026-06-11
US	K244014	i-STAT CG4+ cartridge with the i-STAT 1 System	2025-05-02
BR	10055310988	i-STAT CARTRIDGE EC8 +	Class II
BR	10055310968	PORTABLE CLINICAL ANALYSER i-STAT E ACESSORIOS	Class II
BR	80146501239	I-STAT CARTRIDGE CG4+	Class II
CA	15547	I-STAT PORTABLE CLINICAL SYSTEM	Class III

ABBOTT POINT OF CARE CANADA LIMITED

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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