Nanosonics L T D

FDA Filings

This page includes the latest FDA filings for Nanosonics L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

AUSTRALIA

AUSTRALIAN STOCK EXCHANGE

NAN

DUNS 741021943

FDA Registration(s)

• Registration Number: 3006564498
• FEI Number: 3006564498
• Name: NANOSONICS LIMITED
• Owner & Operator: Nanosonics Limited
• Contact Address: 14 Mars Road ; Lane Cove AU-NSW New South Wales 2066 AU
• Official Correspondent:
  • FREDERIC Bustos
  • 61-2-80631600-x
• US Agent:
  • Michael van der Woude
  • Emergo Global Representation LLC
  • 512 3279997
  • 512 3279998
  • USAgent@ul.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 14 Mars Road ; Lane Cove New South Wales, 2066 AU
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 09350855000566 NANOSONICS LIMITED	trophon Curved Probe Positioner N00099	2022-07-18
GUDID 09350855000542 NANOSONICS LIMITED	trophon Chemical Indicator N05003	2022-05-20
GUDID 09350855000054 NANOSONICS LIMITED	Trophon Chemical Indicator	2021-02-19
GUDID 09350855000047 NANOSONICS LIMITED	Trophon Chemical Indicator	2021-02-19
GUDID 09350855000184 NANOSONICS LIMITED	trophon2	2020-09-09
GUDID 09350855000139 NANOSONICS LIMITED	Trophon EPR	2020-09-09
GUDID 09350855000115 NANOSONICS LIMITED	Trophon EPR	2020-09-09
GUDID 09350855000108 NANOSONICS LIMITED	Trophon EPR	2020-09-09
GUDID 09350855000092 NANOSONICS LIMITED	Sonex-HL	2020-09-09
GUDID 09350855000290 NANOSONICS LIMITED	Clean Ultrasound Probe Cover	2019-07-17
GUDID 09350855000177 NANOSONICS LIMITED	trophon Chemical Indicator	2019-06-24
GUDID 09350855000160 NANOSONICS LIMITED	trophon Sonex-HL	2019-06-24
GUDID 09350855000078 NANOSONICS LIMITED	Sonex-HL	2019-05-03
PMN K173865 | OUJ NANOSONICS LIMITED	trophon2	2018-06-05
PMN K173865 Nanosonics Limited	Trophon2	2018-04-24
FFY NANOSONICS LIMITED	trophon Curved Probe Positioner	2017-05-05
FFF NANOSONICS LIMITED	Clean Ultrasound Probe Cover	2016-11-04
LRJ NANOSONICS LIMITED	Ultrasound Probe Drying Wipes	2016-07-19
LRJ NANOSONICS LIMITED	Ultrasound Probe Cleaning Wipes	2016-07-19
OUG NANOSONICS LIMITED	trophon Connect	2013-07-30
OUG NANOSONICS LIMITED	trophon AcuTrace Operator Card	2013-07-30
OUG NANOSONICS LIMITED	trophon AcuTrace Medical Instrument Tag	2013-07-30
PMN K103126 | JOJ NANOSONICS LIMITED	Trophon Chemical Indicator	2011-03-07
PMN K103059 | OUJ NANOSONICS LIMITED	Trophon Sonex-HL	2011-03-07
PMN K103059 | OUJ NANOSONICS LIMITED	Trophon EPR	2011-03-07
PMN K103126 NANOSONICS LIMITED	TROPHON CHEMICAL INDICATOR	2011-03-03
PMN K103059 NANOSONICS LIMITED	TROPHON	2011-02-24

Related Finance Registrations

NCAGE Code	Z13Z5	NANOSONICS LIMITED
CAGE Code	Z13Z5	NANOSONICS LIMITED

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092429052	Sydney,Australia -> Long Beach, California	MEDICAL EQUIPMENT BOTTLE BUNG AND CAPS INNER PCS-382 CARTONS PACKED ON 20 PALLETS HS CODE: 8419.20,3915.90,3923.50	382 CTN
202007153464	Sydney,Australia -> Long Beach, California	MEDICAL EQUIPMENT(LOADED ON 7 PALLETS)	200 CTN
202007153464	Sydney,Australia -> Long Beach, California	MEDICAL EQUIPMENT (LOADED ON 2 PALLETS)	200 CTN
202007114108	Sydney,Australia -> Long Beach, California	MEDICAL EQUIPMENT(LOADED ON 7 PALLETS)	200 CTN
202007114108	Sydney,Australia -> Long Beach, California	MEDICAL EQUIPMENT (LOADED ON 2 PALLETS)	200 CTN
202007091939	Sydney,Australia -> Long Beach, California	MEDICAL EQUIPMENT	176 CTN
202007091936	Sydney,Australia -> Long Beach, California	A01054 HELIOS BUNG/VENT ASSEMBLY X 57000 M01088 HELIOS BOTTLE BODY X 84700 M000891 BOTTLE CAP BLACK US X 45500	238 CTN
202007039851	Sydney,Australia -> Long Beach, California	MEDICAL EQUIPMENT(LOADED ON 7 PALLETS)	200 CTN
202007039851	Sydney,Australia -> Long Beach, California	MEDICAL EQUIPMENT (LOADED ON 2 PALLETS)	200 CTN
2020070212746	Sydney,Australia -> Long Beach, California	MEDICAL EQUIPMENT(LOADED ON 7 PALLETS)	200 CTN
2020070212746	Sydney,Australia -> Long Beach, California	MEDICAL EQUIPMENT (LOADED ON 2 PALLETS)	200 CTN
202006291634	Sydney,Australia -> Long Beach, California	A01054 HELIOS BUNG/VENT ASSEMBLY X 57000 M01088 HELIOS BOTTLE BODY X 84700 M000891 BOTTLE CAP BLACK US X 45500	238 CTN