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Data / Medical devices / Australia / IBD Medical Trading Pty Ltd.

IBD Medical Trading Pty Ltd.: FDA-registered device maker in Ultimo New South Wales, Australia, 1 510(k) clearance

IBD Medical Trading Pty Ltd. is registered with the FDA (registration 3016815268) in Ultimo New South Wales, Australia. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 31, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3016815268
Address
31 / 330 Wattle Street, Ultimo New South Wales, Australia, 2007
Owner or operator
IBD Medical Trading Pty Ltd. (10071858)
Roles
Exporter to the US, Manufacturer, Repackager or relabeler
First device listed
April 24, 2020
Registered through
2026
Brand names listed
Adhesive Sensor Patch, Glucology Diabetes Socks, Glucology Insulin Cooling Bag, Glucology Pocket Needle Container, Glucology Pump Belt, Glucology Insulin Pump Belt

Devices it lists

DeviceProduct codeClassRoleSource
Adaptor, Holder, SyringeIQG1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bandage, ElasticFQM1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Container, SharpsMMK2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Stocking, Medical Support (For General Medical Purposes)FQL1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the US, Repackager or relabeleraccessdata.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
May 31, 2019K190240Tiger Sharps ContainersMMKSubstantially EquivalentInternational Marketing Specialists, Inc.accessdata.fda.gov

Compare with other makers

Updated May 31, 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.