Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003589956

FEI Number

3003589956

Entity Name

Flextronics Manufacturing (Singapore) Pte Ltd

City/State/Country

SINGAPORE South East, SG

Establishment Address

1 Kallang Place, SINGAPORE South East 339211, SG

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

i-STAT Portable Clinical Analyzer A7 Anesthesia System Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System FACS LOADER SYSTEM 336574 and 338313 Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium Clarus (700) MetaNeb 4 System ePM Series Patient Monitors SC+ Hemodialysis Machine i-STAT hs-TnI Cartridge with the i-STAT 1 System i-STAT 1® Wireless Analyzer Cirrus HD-OCT Model 6000 A4 Anesthesia System A5 Anesthesia System Monarch Airway Clearance System Vest® System; Vest 105; Vest 205 CELL-DYN Sapphire System Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S Maximus System BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 CELL-DYN Ruby System TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite A8, A9 Anesthesia System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-04-13
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2025-12-15
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-11-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-11-26
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-11-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-01-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-01-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-01-23
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2014-04-04
NHJ	Device, Positive Pressure Breathing, Intermittent	Anesthesiology	Class 2	868.5905	2014-09-16
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-11-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-11-26
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-11-26
QER	Camera, Ophthalmic, Slit-Scanning	Ophthalmic	Class 2	886.1120	2026-03-03
NHJ	Device, Positive Pressure Breathing, Intermittent	Anesthesiology	Class 2	868.5905	2017-03-27
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2025-11-26
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2025-11-26
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2025-11-26
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-11-26
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2025-11-26
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-11-26
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2025-11-26
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-11-26
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2024-11-06
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2024-11-06
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2026-02-24
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2026-02-24
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-01-12
OBO	Tomography, Optical Coherence	Ophthalmic	Class 2	886.1570	2024-09-05
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2025-12-15
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2025-12-15
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2025-12-15
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2025-12-15
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2025-12-15
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2025-12-15
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2025-12-15
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2025-12-15
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2025-12-15
BYI	Percussor, Powered-Electric	Anesthesiology	Class 2	868.5665	2017-03-27
BYI	Percussor, Powered-Electric	Anesthesiology	Class 2	868.5665	2010-02-24
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2011-12-22
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-11-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-11-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-11-26
NHJ	Device, Positive Pressure Breathing, Intermittent	Anesthesiology	Class 2	868.5905	2022-09-21
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2017-03-27
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2011-12-22
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-11-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-11-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-11-26
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2026-03-24

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
K811074	Reagents Applications, Inc.	GLUCOSE REAGENT-ENZYMATIC-COLOR 500	1981-04-29
K936212	Heraeus Kulzer, Inc.	GLUCOFILM TEST STRIPS	1994-05-10
K252746	Drägerwerk AG Co. Kgaa	Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)	2026-05-21
K191007	Supersonic Imagine	Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems	2019-10-25
K974588	Rimed , Ltd.	INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD	1998-08-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0378-06	Instrumentation Laboratory Co.	2	GEM PREMIER 3000
Z-2165-2011	Instrumentation Laboratory Co.	2	Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus
Z-0008-2011	GE Healthcare, LLC	2	GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
Z-0008-2014	Draeger Medical, Inc.	2	Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.
Z-0009-2011	GE Healthcare, LLC	2	GE Datex-Ohmeda Avance Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003589956. Last updated year: 2026. Please use registration number 3003589956 when referencing this establishment in official correspondence.