Data / Medical devices / Singapore / Jabil Circuit (Singapore) Pte Ltd

Jabil Circuit (Singapore) Pte Ltd: FDA-registered device maker in Singapore Central Singapore, Singapore, 1 510(k) clearance

Name: Jabil Circuit (Singapore) Pte Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Jabil Circuit (Singapore) Pte Ltd is registered with the FDA (registration 3009247326) in Singapore Central Singapore, Singapore. It lists 15 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 6, 2016. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3009247326
Address: 16 Tampines Industrial Crescent, Singapore Central Singapore, Singapore, 528604
Owner or operator: Jabil Inc. (9074019)
Roles: Contract manufacturer, Exporter to the US
First device listed: November 10, 2011
Registered through: 2027
Brand names listed: BIS EEG VISTA MONITOR SYSTEM AND BISX, BIS Advance pEEG Module, Elvie Stride, Elvie Stride 2, KANGAROO EPUMP and Joey Pump, Kangaroo Connect Enteral Feeding Pump Kangaroo Connect Pole Clamp, Kendall SCD, MX3 Diagnostic Ultrasound System and more

Devices it lists

Device	Product code	Class	Role	Source
Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure	PWA	1	Contract manufacturer	accessdata.fda.gov
Burst Suppression Detection Software For Electroencephalograph	ORT	2	Contract manufacturer	accessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific Connectors	PIF	2	Contract manufacturer	accessdata.fda.gov
Index-Generating Electroencephalograph Software	OLW	2	Contract manufacturer	accessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph Software	OLT	2	Contract manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Contract manufacturer	accessdata.fda.gov
Pump, Breast, Powered	HGX	2	Contract manufacturer	accessdata.fda.gov
Pump, Infusion, Enteral	LZH	2	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Reduced- Montage Standard Electroencephalograph	OMC	2	Contract manufacturer	accessdata.fda.gov
Sleeve, Limb, Compressible	JOW	2	Contract manufacturer	accessdata.fda.gov
Stand, Infusion	FOX	1	Contract manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Contract manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Contract manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Contract manufacturer	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 6, 2016	K153074	Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal	LZH	Substantially Equivalent	Covidien	accessdata.fda.gov

Compare with other makers

Updated July 6, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.