Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd.

FDA Device Registration & Listing · Shenzhen Guangdong, CN · Registration 3007421145

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
3007421145
FEI Number
3004173703
Entity Name
Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd.
City/State/Country
Shenzhen Guangdong, CN
Establishment Address
3-6/F, Building 1, 3B/F, 4/F, Building 2, and 5-7/F, Building 3, Rundongsheng Industrial Park, Longteng, Xixiang, Baoan District, Shenzhen Guangdong 518126, CN
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

Freestyle Lite Blood Glucose Monitoring System. PRT10500-901 ASSY, METER, MG/DL, USA, CR, FREESTYLE LITE FREESTYLE LITE BLOOD GLUCOSE MONITO FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM FreeStyle Precision Neo H Blood Glucose Monitoring System FreeStyle Libre Pro (System D, PRT29000-506,PRT29000-508, PRT 129000-416 Freestyle Libre Flash Glucose Monitoring System:PRT29000-510 - ASSY, READER, SYSTEM D, MG/DL, 29000, EN-US , GOVT Freestyle Libre Flash Glucose Monitoring System (System A, PRT22175-123, PRT22175-124, PRT26662-005 (S/A) Freestyle Libre Flash Glucose Monitoring System:PRT22175-137 - ASSY, READER, SYSTEM A, MG/DL, 22175, EN-US/ES-US, GOVT, NFRS Freestyle Libre Flash Glucose Monitoring System:PRT22175-135 - ASSY, READER, SYSTEM A, MG/DL, 22175, EN-US/ES-US, GOVT Freestyle Libre 2 Flash Glucose 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 FreeStyle Freedom Lite Blood Glucose Monitoring System LFR Glucose dehydrogenase, glucose, OTC, Freestyle

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 2016-04-22
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2016-04-22
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2008-12-09
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2017-09-25
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2017-09-25
MDS Sensor, Glucose, Invasive Unknown Class 3 N/A 2016-09-28
PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated Unknown Class 3 N/A 2017-10-11
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
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
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2017-09-25
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2017-09-25
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

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
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
Z-0033-2026 Medtronic MiniMed, Inc. 3
Medtronic, Simplera Sensor, REF: MMT-5100JD1

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007421145. Last updated year: 2026. Please use registration number 3007421145 when referencing this establishment in official correspondence.
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