HomeUSANANOSONICS LIMITED

NANOSONICS LIMITED

USA · Macquarie Park
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Canada, Singapore, Australia, Hong Kong, Israel, Russia — 7 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
5listed device types
Class I 2Class II 3Class III 0
plus 10 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
2 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
10active ARTG entries
Class I 9IIb 1
HKHong KongMDACS
1valid listings
Class III 1
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States10 registration records, 7 510(k), 0 PMA
Manufacturer names merged into this page: NANOSONICS, INC. · NANOSONICS LIMITED

Company information

Country
USA
City
Macquarie Park

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

22011 · K103126
12018 · K173865
12024 · K241536
22025 · K250434
12026 · K253267

FDA listed device types

High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist 1Automated Endoscope Channel Cleaner 1Indicator, Physical/Chemical Sterilization Process 1Medical Device Data System 1Cover, Biopsy Forceps 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253267CORIS System2026-03-05
USK250434trophon22025-08-05
USDEN240018CORIS System2025-03-19

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