Data / Medical devices / Australia / Nanosonics Limited
Nanosonics Limited: FDA-registered device maker in Macquarie Park New South Wales, Australia, 6 510(k) clearances
Nanosonics Limited is registered with the FDA (registration 3006564498) in Macquarie Park New South Wales, Australia. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 5, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006564498
- Address
- 3-5 Thomas Holt Drive, Macquarie Park New South Wales, Australia, 2113
- Owner or operator
- Nanosonics Limited (10035569)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- March 7, 2011
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Endoscope Channel Cleaner | SEW | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Cover, Biopsy Forceps | FFF | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist | OUJ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| March 5, 2026 | K253267 | CORIS System | SEW | Substantially Equivalent | Nanosonics Limited | accessdata.fda.gov |
| August 5, 2025 | K250434 | trophon2 | OUJ | Substantially Equivalent | Nanosonics | accessdata.fda.gov |
| September 27, 2024 | K241536 | trophon Wireless Ultrasound Probe Holder | OUJ | Substantially Equivalent | Nanosonics Limited | accessdata.fda.gov |
| April 24, 2018 | K173865 | trophon2 | OUJ | Substantially Equivalent | Nanosonics Limited | accessdata.fda.gov |
| March 3, 2011 | K103126 | TROPHON CHEMICAL INDICATOR | JOJ | Substantially Equivalent | Nanosonics Limited | accessdata.fda.gov |
| February 24, 2011 | K103059 | TROPHON | OUJ | Substantially Equivalent | Nanosonics Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of Cover, Biopsy Forceps
- All makers of Medical Device Data System
- All makers of High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
Updated March 5, 2026. 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.