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Impedimed Limited

Australia · Lindfield New South

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Australia, Hong Kong — 3 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

4listed device types

Class I 0Class II 4Class III 0

plus 15 registration records and 12 510(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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 2IIa 2

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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 States15 registration records, 12 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: Impedimed Limited · IMPEDIMED, INC.

Business registration

ABN: 65089705144
Registration status: Active
Legal form: Australian Public Company
Registered address: NSW, 2070

Business registration data from Australian Business Register, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12011

12013

22017

12018

12019

12020

12021

32023

12026

FDA listed device types

Adjunct Monitor, Protein Calorie Malnutrition 1Plethysmograph, Impedance 1Monitor, Extracellular Fluid, Lymphedema, Extremity 1Analyzer, Body Composition 1

Market	Identifier	Name	Class / date
US	K253224	MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)	2026-01-28
US	K232089	SOZO Pro	2023-10-17
US	K230530	SOZO Pro	2023-05-04

Impedimed Limited

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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