FDA Registration Active 🇸🇬 Singapore

Flextronics Manufacturing (Singapore) Pte Ltd

Reg #: 3003589956 · FEI: 3003589956 · Expires 2026
Products
32
Proprietary Names
35
Establishment Types
1
Classifications
32

Registration Details

Registration Name
Flextronics Manufacturing (Singapore) Pte Ltd
Registration Number
3003589956
FEI Number
3003589956
Status
Active
Expiry Year
2026
Initial Importer
No
Address
1 Kallang Place
City
SINGAPORE South East
Country
SG

Owner / Operator

Firm Name
Flextronics International USA, Inc.
Operator Number
9006592
Address
12455 Research Blvd
City
Austin
State
TX
Postal Code
78759
Country
US
Correspondent
Chad Ashton

US Agent

Business Name
FLEXTRONICS INTERNATIONAL USA, INC.
Contact Name
Chad Ashton
Address
12455 Research Blvd
City
Austin
State
TX
ZIP
78759
Country
US
Phone
901 8712423

Products

Device Name Product Code
Glucose Oxidase, Glucose CGA
Gas-Machine, Anesthesia BSZ
System, Imaging, Pulsed Doppler, Ultrasonic IYN
System, Imaging, Pulsed Echo, Ultrasonic IYO
Transducer, Ultrasonic, Diagnostic ITX
Counter, Differential Cell GKZ
Device, Positive Pressure Breathing, Intermittent NHJ
Camera, Ophthalmic, Slit-Scanning QER
Detector And Alarm, Arrhythmia DSI
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
Computer, Blood-Pressure DSK
Oximeter DQA
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
Continuous Measurement Thermometer FLL
Monitor, St Segment With Alarm MLD
System, Measurement, Blood-Pressure, Non-Invasive DXN
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
Immunoassay Method, Troponin Subunit MMI
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
Tomography, Optical Coherence OBO
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
Analyzer, Gas, Oxygen, Gaseous-Phase CCL
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
Percussor, Powered-Electric BYI
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
Flow Cytometric Reagents And Accessories. OYE

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 MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) CIRRUS HD-OCT Model # 500, 5000, 6000 Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fib Consona N6 Diagnostic Ultrasound System ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02) VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor CLARUS 500 MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/ AnesusME7T/ MX7P/ MX7W/ MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System i-STAT CG8+ cartridge with the i-STAT 1 System BD FACS™ Loader Percussor, Powered-Electric, Vest, Blue Tooth Consona N9 Diagnostic Ultrasound System

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)