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Abbott Ireland Diabetes Care

Ireland · Donegal Town Donegal

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

17listed device types

Class I 5Class II 10Class III 2

plus 58 registration records and 39 510(k), 113 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class I 2Class II 8

22 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

15active device licences

Class II 5Class III 10

37 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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 States58 registration records, 39 510(k), 113 PMA, 30 excluded

Brazil10 confirmed, 4 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada15 confirmed, 6 excluded

Manufacturer names merged into this page: Abbott Ireland Diabetes Care · ABBOTT DIABETES CARE LIMITED · ABBOTT DIABETES CARE INC. · ABBOTT DIABETES CARE LTD. · ABBOTT DIABETES CARE LTD · ABBOTT DIABETES CARE

FDA 510(k) clearances by year

12001

12002

12003

32005

32006

22007

32008

22009

22010

12012

22013

12014

12015

12016

12017

12020

32021

22022

32023

22024

FDA listed device types

showing 8 of 17

Continuous Glucose Monitor Secondary Display 1Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter 1Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1Injection Data Capture Device 1Integrated Continuous Glucose Monitoring System, Factory Calibrated 1Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems 1Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature 1Multiple Use Blood Lancet For Single Patient Use Only 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233861	Libre Rio Continuous Glucose Monitoring System	2024-06-07
US	K233537	FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System	2024-04-23
US	K223435	FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System	2023-04-13
BR	80146501823	FreeStyle Optium Blood H Glucose Monitoring System/ Sistema de Monitor	Class II
BR	80146501868	FREESTYLE PRECISION PRO BLOOD GLUCOSE TEST STRIP / FREESTYLE PRECISION	Class II
BR	80146501881	FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING METER KI	Class II
CA	1975	PRECISION ELECTRODES	Class III
CA	1976	MEDISENSE GLUCOSE CONTROLS	Class III
CA	11494	PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM	Class III

Abbott Ireland Diabetes Care

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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