Flextronics Manufacturing Aguascalientes, S.A de C.V

FDA Device Registration & Listing · Aguascalientes, MX · Registration 3003600763

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
3003600763
FEI Number
3003600763
Entity Name
Flextronics Manufacturing Aguascalientes, S.A de C.V
City/State/Country
Aguascalientes, MX
Establishment Address
Boulevard a Zacatecas, Km 9.5, Jesús María, Aguascalientes 20900, MX
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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Bed - Pediatric, Open Hospital, Cub, HAVASU IV Pole, (Accessory) Discovery Ci; Discovery Wi; Horizon A; Horizon C; Horizon Ci; Horizon W; Horizon Wi PEGASUS PRT19550-220: FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM FreeStyle Libre 3 Reader Kits FreeStyle Libre 2 Reader Kits Instinct Sensor FreeStyle Libre 2 Plus Sensor Kits FreeStyle Libre 3 Plus Sensor Kits LFR Glucose dehydrogenase, glucose, OTC, Freestyle SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM Freestyle Libre 2 Flash Glucose Monitoring System PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM PRECISION XTRA ADVANCED DIABETES MA FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2023-07-05
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated Clinical Chemistry Class 2 862.1355 2023-07-05
FMS Bed, Pediatric Open Hospital General Hospital Class 2 880.5140 2010-12-08
KGI Densitometer, Bone Radiology Class 2 892.1170 2016-09-27
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2014-11-26
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2014-11-26
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2014-11-26
JQP Calculator/Data Processing Module, For Clinical Use Clinical Chemistry Class 1 862.2100 2014-11-26
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 2013-10-24
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2013-10-24
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2009-01-05
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2009-01-05
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2009-01-05
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2016-09-28
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
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2009-02-26
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2009-02-26
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2009-02-26
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2016-09-28

Official Correspondent

Chad Ashton

US Agent Details

Chad Ashton Business: FLEXTRONICS INTERNATIONAL USA, INC. Email: chad.ashton@flex.com Phone: (901) 8712423

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
K983273 Medical Systems, Inc. XCT 2000 L PQCT BONE DENSITOMETER 1998-10-29
K973662 Boehringer Mannheim Corp. ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS 1997-12-15
K781173 Instrumentation Laboratory CO COMPUTER INTERFACE IL 814 1978-09-14

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
Z-0007-04 Misys Healthcare Systems 1
Calculator/Data Processing Module for Clinical Use

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003600763. Last updated year: 2026. Please use registration number 3003600763 when referencing this establishment in official correspondence.
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