FDA Registration
Active
🇦🇺 Australia
NANOSONICS LIMITED
Reg #: 3006564498
·
FEI: 3006564498
·
Expires 2026
Products
5
Proprietary Names
0
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- NANOSONICS LIMITED
- Registration Number
- 3006564498
- FEI Number
- 3006564498
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7-11 Talavera Road
- City
- Macquarie Park New South Wales
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K250434
Owner / Operator
- Firm Name
- Nanosonics Limited
- Operator Number
- 10035569
- Address
- 7-11 Talavera Road
- City
- Macquarie Park
- State
- New South Wales
- Postal Code
- 2113
- Country
- AU
- Correspondent
- Tim Croft
US Agent
- Business Name
- Nanosonics, Inc.
- Contact Name
- Nancy Kaiser
- Address
- 7205 E 87th St
- City
- Indianapolis
- State
- IN
- ZIP
- 46256
- Country
- US
- [email protected]
- Phone
- 844 8767466
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist | OUJ | Class 2 | Radiology | No | 2025-08-08 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2013-07-30 |
| Automated Endoscope Channel Cleaner | SEW | Class 2 | General Hospital | No | 2026-05-04 |
| Cover, Biopsy Forceps | FFF | Class 1 | Gastroenterology, Urology | No | 2016-11-04 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2011-03-07 |
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility