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Abbott Diagnostics Korea Inc.

Korea, Republic · Yongin-Si Gyeonggi

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Taiwan, 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

1listed device types

Class I 0Class II 0Class III 0unclassified 1

plus 1 registration records and 28 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class II 7

29 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

14valid device licences

Class I 6Class II 8

SGSingaporeHSA SMDR

20device registrations

CLASS B 4CLASS C 14CLASS D 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

11active ARTG entries

IVD Class 1 3IVD Class 2 3IVD Class 3 5

HKHong KongMDACS

14valid listings

IVD C 13IVD D 1

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

8active registrations

Class 2a 3Class 2b 4Class 3 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 States1 registration records, 28 510(k), 0 PMA, 66 excluded

Brazil7 confirmed, 29 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada0 confirmed, 31 excluded

Manufacturer names merged into this page: Abbott Diagnostics Korea Inc. · ABBOTT DIAGNOSTICS KOREA INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K964185	IMX CA 125	1997-11-04
US	K972182	ABBOTT STREP A CONTROLS	1997-08-13
US	K961439	ABBOTT CELL-DYN 4000 SYSTEM	1996-10-18
BR	10071770925	Bioline RSV	Class II
BR	10071779013	Lancetas de segurança Unistik Touch	Class II
BR	10071770923	Bioline Rota/Adeno	Class II

Abbott Diagnostics Korea Inc.

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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