Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004782476

FEI Number

3004782476

Entity Name

Impedimed Limited

City/State/Country

Lindfield New South Wales, AU

Establishment Address

Suite 31C, 12-18 Tryon Rd., Lindfield New South Wales 2070, AU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Impedimed Limited (Owner Number: 10023581)

Owner / Operator Contact Address

Suite 31C, 12-18 Tryon Rd., Lindfield, AU-NSW 2070, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K130338

PMA Number

N/A

All Registered Proprietary Names

SOZO Pro L-Dex U400 SOZO SOZO Extracellular Fluid Analysis L-Dex U400 Bis Extra Cellular Fluid Analysis

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2025-05-13
OBH	Monitor, Extracellular Fluid, Lymphedema, Extremity	Cardiovascular	Class 2	870.2770	2012-12-14
OBH	Monitor, Extracellular Fluid, Lymphedema, Extremity	Cardiovascular	Class 2	870.2770	2017-09-13
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2019-01-29
OBH	Monitor, Extracellular Fluid, Lymphedema, Extremity	Cardiovascular	Class 2	870.2770	2007-12-04
OBH	Monitor, Extracellular Fluid, Lymphedema, Extremity	Cardiovascular	Class 2	870.2770	2009-09-25
OBH	Monitor, Extracellular Fluid, Lymphedema, Extremity	Cardiovascular	Class 2	870.2770	2013-12-13

Official Correspondent

No official correspondent registered.

US Agent Details

Richard Hines Business: ImpediMed Inc. Email: rhines@impedimed.com Phone: (760) 5852104

Related Public Records

Same Entity

Impedimed Limited

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004782476. Last updated year: 2026. Please use registration number 3004782476 when referencing this establishment in official correspondence.