Abbott Ireland Diabetes Care

FDA Device Registration & Listing · Donegal Town, IE · Registration 3007031103

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007031103
FEI Number
3007031103
Entity Name
Abbott Ireland Diabetes Care
City/State/Country
Donegal Town, IE
Establishment Address
Donegal Town, Co. Donegal, Donegal Town Donegal, IE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ABBOTT LABORATORIES (Owner Number: 1415939)
Owner / Operator Contact Address
100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K092638
PMA Number
N/A

All Registered Proprietary Names

FreeStyle InsuLinx Blood Glucose Monitoring System FreeStyle Freedom Lite Blood Glucose Monitoring System FreeStyle Lite Blood Glucose Monitoring System FreeStyle Blood Glucose Test Strips

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2015-11-01
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2015-11-01
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2015-11-01
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2015-11-01
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2015-11-01
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2015-11-01
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2010-06-28
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2010-06-28

Official Correspondent

No official correspondent registered.

US Agent Details

Rodney Huang Business: Abbott Diabetes Care Inc. Email: rodney.huang@abbott.com Phone: (510) 2392614

Related Public Records

Same Entity

ABBOTT LABORATORIES
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004032053 Abbott S.r.l. Milan Lombardy, IT
3011706799 Abbott Medical Atlanta, GA, US
1628664 ABBOTT LABORATORIES IRVING, TX, US
3023268435 Abbott Automation Solutions GmbH Hamburg, DE
3001883144 St. Jude Medical Brasil Ltda. Belo Horizonte Minas Gerais, BR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K973662 Boehringer Mannheim Corp. ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS 1997-12-15
K150396 Apex BioTechnology Corp. Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips 2015-10-14
K150833 Andon Health Co, Ltd. iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System 2015-12-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2009 Lifescan Inc 2
One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06 Abbott Laboratories Medisense Products 2
FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06 Abbott Laboratories Medisense Products 2
Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06 Abbott Laboratories Medisense Products 2
Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

Similar Registrations

Registration Number Establishment Name Location
3014353121 VIDAN DIAGNOSTICS, LLC San Antonio, TX, US
3012118659 ASCENSIA DIABETES CARE HOLDINGS AG Basel Basel-Stadt, CH
1810909 Ascensia Diabetes Care US Inc. Valhalla, NY, US
2954323 ABBOTT DIABETES CARE INC. ALAMEDA, CA, US
3003741676 ANDON HEALTH CO., LTD TIANJIN, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007031103. Last updated year: 2026. Please use registration number 3007031103 when referencing this establishment in official correspondence.
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