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ABBOTT DIAGNOSTICS MEDICAL CO., LTD.

Japan · Matsudo

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 10 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

75listed device types

Class I 11Class II 32Class III 32

plus 292 registration records and 87 510(k), 3,584 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

38registered devices

Class I 17Class II 21

235 including historic records

SASaudi ArabiaSFDA

5registered imported devices

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

CACanadaMDALL

12active device licences

Class II 10Class III 1Class IV 1

242 including historic records

TWTaiwanTFDA

7valid device licences

Class I 2Class II 2Class III 3

SGSingaporeHSA SMDR

5device registrations

CLASS B 1CLASS C 1CLASS D 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

10active ARTG entries

IVD Class 1 7IVD Class 2 1IVD Class 3 1IVD Class 4 1

HKHong KongMDACS

4valid listings

IVD D 4

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

6active registrations

Class 2a 2Class 2b 2Class 3 2

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 States292 registration records, 87 510(k), 3,584 PMA, 63 excluded

Brazil38 confirmed, 28 excluded

Saudi Arabia5 confirmed, 1 excluded

Canada12 confirmed, 29 excluded

Manufacturer names merged into this page: Abbott Medical · ABBOTT MEDICAL · ABBOTT DIAGNOSTICS MEDICAL CO., LTD.

FDA 510(k) clearances by year

21981

21982

51983

31984

41985

11986

51987

21988

11989

11996

21997

42019

42020

52021

82022

102023

82024

132025

72026

FDA listed device types

showing 8 of 75

Sizer, Heart-Valve, Prosthesis 1Instrument, Surgical, Disposable 1Holder, Heart-Valve, Prosthesis 1Magnet, Test, Pacemaker 1Tools, Pacemaker Service 1Tape, Measuring, Rulers And Calipers 1Cardiovascular Delivery Catheter System Positioning And Stabilization Device 1Medical Device Data System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K262006	EnSite X EP System	2026-07-15
US	K261631	Amplatzer TorqVue Exchange System	2026-06-17
US	K253459	OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)	2026-04-24
BR	10332340471	Electrophysiology Cable	Class I
BR	10332340414	Cabo Adaptador NeuroTherm	Class I
BR	10332340500	Agilis HisPro Slitter	Class I
SA	ME0000014762SFDAA00006	Lift	—
SA	ME0000014762SFDAA00004	Stabilizer	—
CA	1345	FAST-CATH(TM) HEMOSTASIS INTRODUCERS	Class II
CA	27298	ULTIMUM HEMOSTASIS INTRODUCER	Class II
CA	69836	ABBOTT MEDICAL VESSEL DILATORS	Class II

ABBOTT DIAGNOSTICS MEDICAL CO., LTD.

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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