Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011536730

FEI Number

3011536730

Entity Name

Flextronics International USA

City/State/Country

Buffalo Grove, IL, US

Establishment Address

700 Corporate Grove Drive, Buffalo Grove, IL 60089, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Flextronics International USA, Inc. (Owner Number: 9006592)

Owner / Operator Contact Address

12455 Research Blvd, Austin, TX 78759, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FreeStyle Libre 3 Reader Kits FreeStyle Libre 2 Reader Kits Instinct Sensor FreeStyle Libre 2 Plus Sensor Kits FreeStyle Libre 3 Plus Sensor Kits FreeStyle Libre 3 Continuous Glucose Monitoring System FreeStyle Libre 2 Flash Glucose Monitoring System FreeStyle Libre 2 Flash Glucose Monitoring System FreeStyle Libre Flash Glucose Monitoring System Freestyle Libre 2 Flash Glucose Monitoring System Libre Rio Continuous Glucose Monitoring System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QLG	Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems	Clinical Chemistry	Class 2	862.1355	2025-07-14
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2025-07-14
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Clinical Chemistry	Class 2	862.1355	2025-07-14
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2023-09-19
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Clinical Chemistry	Class 2	862.1355	2023-09-19
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Clinical Chemistry	Class 2	862.1355	2020-03-30
PZE	Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated	Unknown	Class 3	N/A	2019-11-01
QLG	Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems	Clinical Chemistry	Class 2	862.1355	2020-06-16
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2020-06-16
SBH	Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter	Clinical Chemistry	Class 2	862.1355	2024-06-12

Official Correspondent

Chad Ashton

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Flextronics International USA, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003027964	Flex Precision Plastics Solutions (Switzerland) AG	Hagglingen Aargau, CH
3008886285	Flextronics International Kft	Budapest, HU
3006126537	FLEXTRONICS INTERNATIONAL GMBH	ALTHOFEN Karnten, AT
3021010223	Flex Precision Plastics Solutions AG	Kussnacht Schwyz, CH
3022473387	Flextronics Medical Molding (Shenzhen) Co., Ltd	Shenzhen Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
3006537560	Flextronics America, LLC	Austin, TX, US
2954323	ABBOTT DIABETES CARE INC.	ALAMEDA, CA, US
3009171251	UPS SUPPLY CHAIN SOLUTIONS, INC.	Louisville, KY, US
3002807314	Synergy Health Ireland Ltd	Tullamore Offaly, IE
3008606429	RR Donnelley GTS Poland Sp. z o.o.	Lodz Lodzkie, PL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011536730. Last updated year: 2026. Please use registration number 3011536730 when referencing this establishment in official correspondence.