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Home›USA›Abbott Point of Care, Inc.

Abbott Point of Care, Inc.

USA · Abbott Park
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Hong Kong, Israel, Russia — 8 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
0valid device licences
SGSingaporeHSA SMDR
10device registrations
CLASS B 1CLASS C 9
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
11active ARTG entries
IVD Class 1 3IVD Class 2 5IVD Class 3 3
HKHong KongMDACS
11valid listings
IVD C 11
ILIsraelAMAR
4registrations
RURussiaRoszdravnadzor
2active registrations
Class 1 1Class 2a 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 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
Same-named companies — This database also contains companies with near-identical names: ABBOTT POINT OF CARE CANADA LIMITED. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Abbott Park

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

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)

MarketIdentifierNameClass / date
USK261039i-STAT Crea cartridge with the i-STAT 1 System2026-06-26
USK253051i-STAT hs-TnI cartridge with the i-STAT Alinity System2026-06-11
USK244014i-STAT CG4+ cartridge with the i-STAT 1 System2025-05-02
BR10055310988i-STAT CARTRIDGE EC8 +Class II
BR10055310968PORTABLE CLINICAL ANALYSER i-STAT E ACESSORIOSClass II
BR80146501239I-STAT CARTRIDGE CG4+Class II
CA15547I-STAT PORTABLE CLINICAL SYSTEMClass III

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