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ABBOTT GMBH & CO. KG

Germany · Wiesbaden

✓ Record-verifiedregistrations found in 10 markets

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

137listed device types

Class I 44Class II 89Class III 3unclassified 1

plus 165 registration records and 13 510(k), 31 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

140registered devices

Class I 4Class II 136

253 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

5active device licences

Class II 1Class III 2Class IV 2

52 including historic records

TWTaiwanTFDA

90valid device licences

Class I 3Class II 63Class III 24

SGSingaporeHSA SMDR

144device registrations

CLASS B 77CLASS C 42CLASS D 25

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

39active ARTG entries

IVD Class 1 4IVD Class 2 14IVD Class 3 4IVD Class 4 17

HKHong KongMDACS

101valid listings

IVD B 38IVD C 35IVD D 28

ILIsraelAMAR

32registrations

RURussiaRoszdravnadzor

175active registrations

Class 1 3Class 2a 73Class 2b 74Class 3 25

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 States165 registration records, 13 510(k), 31 PMA, 66 excluded

Brazil140 confirmed, 28 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada5 confirmed, 30 excluded

Manufacturer names merged into this page: ABBOTT GmbH · ABBOTT GMBH · ABBOTT GMBH & CO. KG

FDA 510(k) clearances by year

22018

32019

22021

22022

12024

12025

22026

FDA listed device types

showing 8 of 137

Counter, Differential Cell 1Igm, Antigen, Antiserum, Control 1Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens 1Cardiac C-Reactive Protein, Antigen, Antiserum, And Control 1Ovarian Adnexal Mass Assessment Score Test System 1System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer 1Catalytic Methods, Amylase 1Iga, Antigen, Antiserum, Control 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261825	Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter	2026-07-02
US	K260993	Amplatzer TorqVue Delivery System	2026-04-24
US	K251221	Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)	2025-09-17
BR	10055310837	ALKALINE PHOSPHATASE/FOSFATASE ALCALINA	Class II
BR	10055310839	TOTAL PROTEIN / PROTEÍNA TOTAL	Class II
BR	10055310843	PHOSPHORUS / FÓSFORO	Class II
CA	5202	IMX SYSTEM	Class II
CA	9176	IMX SYSTEM	Class IV
CA	12964	COMMANDER SYSTEM	Class IV