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Data / Medical devices / Australia / Navi Medical Technologies Pty Ltd

Navi Medical Technologies Pty Ltd: FDA-registered device maker in Carlton Victoria, Australia, 1 510(k) clearance

Navi Medical Technologies Pty Ltd is registered with the FDA (registration 3030148766) in Carlton Victoria, Australia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 19, 2025. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

FDA registration number
3030148766
Address
L 2 700 Swanston Street, Carlton Victoria, Australia, 3053
Owner or operator
Navi Medical Technologies Pty Ltd (10093411)
Roles
Complaint file establishment, Manufacturer
First device listed
May 12, 2025
Registered through
2026
Brand names listed
Neonav ECG Tip Location System

Devices it lists

DeviceProduct codeClassRoleSource
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysLJS2Complaint file establishment, Manufactureraccessdata.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
January 19, 2025K241910Neonav ECG Tip Location SystemLJSSubstantially EquivalentNavi Medical Technologiesaccessdata.fda.gov

Compare with other makers

Updated January 19, 2025. 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.