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Data / Medical devices / Singapore / Venture Corporation Limited

Venture Corporation Limited: FDA-registered device maker in Singapore North East, Singapore, 2 510(k) clearances

Venture Corporation Limited is registered with the FDA (registration 3003908598) in Singapore North East, Singapore. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 13, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3003908598
Address
5006 Ang Mo Kio Avenue 5 #05-01/12, Singapore North East, Singapore, 569873
Owner or operator
Venture Corporation Limited (10058887)
Roles
Contract manufacturer, Exporter to the US
First device listed
November 6, 2018
Registered through
2026
Brand names listed
Bellavista 1000 US, Evair, Fisso, Respiration Arm light, SmartLung, Water Bottle Holder for Bellavista Ventilator

Devices it lists

DeviceProduct codeClassRoleSource
Bag, ReservoirBTC1Exporter to the USaccessdata.fda.gov
Compressor, Air, PortableBTI2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)BZO1Exporter to the USaccessdata.fda.gov
Stand, InfusionFOX1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Ventilator, Continuous, Facility UseCBK2Contract manufacturer, Exporter to the USaccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 13, 2019K183364BellavistaCBKSubstantially EquivalentImtmedical AGaccessdata.fda.gov
July 31, 2017K163127bellavista 1000CBKSubstantially EquivalentImtmedical AGaccessdata.fda.gov

Compare with other makers

Updated September 13, 2019. 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.