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
- [email protected]
- Phone
- 901 8712423
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2011-04-13 |
| Gas-Machine, Anesthesia | BSZ | Class 2 | Anesthesiology | No | 2025-12-15 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2025-11-26 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2025-11-26 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2025-11-26 |
| Counter, Differential Cell | GKZ | Class 2 | Hematology | No | 2014-04-04 |
| Device, Positive Pressure Breathing, Intermittent | NHJ | Class 2 | Anesthesiology | No | 2014-09-16 |
| Camera, Ophthalmic, Slit-Scanning | QER | Class 2 | Ophthalmic | No | 2026-03-03 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2025-11-26 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2025-11-26 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2025-11-26 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2025-11-26 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2025-11-26 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2025-11-26 |
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2025-11-26 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2025-11-26 |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | Class 2 | Gastroenterology, Urology | No | 2024-11-06 |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | Class 2 | Gastroenterology, Urology | No | 2024-11-06 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2026-02-24 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2026-02-24 |
| Tomography, Optical Coherence | OBO | Class 2 | Ophthalmic | No | 2024-09-05 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2025-12-15 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2025-12-15 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2025-12-15 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2025-12-15 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2025-12-15 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2025-12-15 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2025-12-15 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2025-12-15 |
| Percussor, Powered-Electric | BYI | Class 2 | Anesthesiology | No | 2017-03-27 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2025-05-15 |
| Flow Cytometric Reagents And Accessories. | OYE | Class 2 | Hematology | No | 2023-10-25 |
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)