Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006564498

FEI Number

3006564498

Entity Name

NANOSONICS LIMITED

City/State/Country

Macquarie Park New South Wales, AU

Establishment Address

7-11 Talavera Road, Macquarie Park New South Wales 2113, AU

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Nanosonics Limited (Owner Number: 10035569)

Owner / Operator Contact Address

7-11 Talavera Road, Macquarie Park, AU-NSW 2113, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OUJ	High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist	Radiology	Class 2	892.1570	2025-08-08
OUJ	High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist	Radiology	Class 2	892.1570	2024-09-29
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2013-07-30
OUJ	High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist	Radiology	Class 2	892.1570	2018-06-05
SEW	Automated Endoscope Channel Cleaner	General Hospital	Class 2	880.6994	2026-05-04
OUJ	High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist	Radiology	Class 2	892.1570	2011-03-07
FFF	Cover, Biopsy Forceps	Gastroenterology, Urology	Class 1	876.1075	2016-11-04

Official Correspondent

Tim Croft

US Agent Details

Nancy Kaiser Business: Nanosonics, Inc. Email: n.kaiser@nanosonics.com Phone: (844) 8767466

Related Public Records

Same Entity

Nanosonics Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
1831301	APPLIED LABORATORIES, INC.	COLUMBUS, IN, US
3008894376	NANOSONICS, INC.	Indianapolis, IN, US
3026606276	KEY ASIC BERHAD	PETALING JAYA Selangor, MY
3043603319	MEDICARE TAGS LIMITED T/A MEDYTRAK	Galway, IE
3002725312	AMERICAN PORTWELL TECHNOLOGY, INC.	Fremont, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006564498. Last updated year: 2026. Please use registration number 3006564498 when referencing this establishment in official correspondence.