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Abbott Laboratories, Inc.

USA · Irving

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, 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

195listed device types

Class I 54Class II 134Class III 3unclassified 4

plus 396 registration records and 898 510(k), 702 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

74registered devices

Class I 31Class II 43

80 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

56active device licences

Class II 30Class III 13Class IV 13

115 including historic records

TWTaiwanTFDA

17valid device licences

Class I 8Class II 9

SGSingaporeHSA SMDR

20device registrations

CLASS B 14CLASS C 3CLASS D 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

10active ARTG entries

IVD Class 1 6IVD Class 2 3Class Im (measuring) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

14registrations

RURussiaRoszdravnadzor

4active registrations

Class 1 1Class 2a 3

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 States396 registration records, 898 510(k), 702 PMA, 60 excluded

Brazil74 confirmed, 27 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada56 confirmed, 24 excluded

Manufacturer names merged into this page: ABBOTT LABORATORIES · Abbott Laboratories de Mexico · Abbott Laboratories (Singapore) Private Limited · ABBOTT LABORATORIES, ABBOTT VASCULAR INC. · ABBOTT LABORATORIES MEDISENSE PROD · ABBOTT LABORATORIES DIAGNOSTICS DIVISION

Business registration

Legal name: ABBOTT LABORATORIES
CIK: 0000001800
Registration status: Active
Listing status: Listed (ABT)

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

FDA 510(k) clearances by year

92006

22007

42008

32009

22010

82011

72012

32013

12014

72015

22016

62017

22018

22019

12021

42022

82023

22024

32025

12026

FDA listed device types

showing 8 of 195

Counter, Differential Cell 1Igm, Antigen, Antiserum, Control 1Turbidimetric, Total Protein 1Enzyme Immunoassay, Benzodiazepine 1Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens 1Cardiac C-Reactive Protein, Antigen, Antiserum, And Control 1Calibrator For Hemoglobin And Hematocrit Measurement 1Ovarian Adnexal Mass Assessment Score Test System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252424	Anti-HCV Next	2026-04-28
US	K243500	ARCHITECT iGentamicin	2025-07-09
US	K243168	Alinity i Rubella IgG	2025-06-20
BR	10055310843	PHOSPHORUS / FÓSFORO	Class II
BR	10055310845	GLUCOSE / GLICOSE	Class II
BR	10055310939	ICT SAMPLE DILUENT / ICT DILUENTE DE AMOSTRA	Class I
CA	68139	SUTURE TRIMMERS	Class IV
CA	11181	KNOT PUSHER	Class II
CA	14494	HEARTFLO ANASTOMOSIS DEVICE (MECHANICALLY DRIVEN)	Class IV

Abbott Laboratories, Inc.

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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