Nanosonics
Ultrasound probe disinfection systems and infection prevention devices.
Nanosonics manufactures ultrasound probe disinfection systems and infection prevention devices from its Sydney operations. The company supplies healthcare systems, laboratories, OEM partners or regulated export customers across its listed primary markets.
- Type
- Manufacturer
- Location
- Sydney, Australia
- Founded
- 2001
- Website
- nanosonics.com.au
- Categories
- Medical & Healthcare Supplies, Industrial Machinery
- Markets
- Australia, United States, Germany, Japan
Verified facts
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
- sanctions-clear (green), checked 2026-08-12 OpenSanctions
- fda-registered (green), checked 2026-08-12 FDA
- debarment-clear (green), checked 2026-08-12 OpenSanctions
- standards-mark-certified (green), checked 2026-08-16 ENERGY STAR certified product database (US EPA / DOE)
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- FDA Registered FDA Establishment Registration
- ENERGY STAR ENERGY STAR Product Finder
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)
- Machinery sold in the EU needs CE marking with a declaration of conformity under the EU machinery rules. European Commission