Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043631

FEI Number

3009638066

Entity Name

CYCLOMEDICA AUSTRALIA PTY LTD

City/State/Country

Kingsgrove New South Wales, AU

Establishment Address

Unit 4, 1 The Crescent, Kingsgrove New South Wales 2208, AU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CYCLOMEDICA AUSTRALIA PTY LTD (Owner Number: 9002789)

Owner / Operator Contact Address

Unit 4, 1 The Crescent, Kingsgrove, AU-NSW 2208, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200916

PMA Number

N/A

All Registered Proprietary Names

Patient Administration Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYT	System, Rebreathing, Radionuclide	Radiology	Class 2	892.1390	2022-10-31

Official Correspondent

No official correspondent registered.

US Agent Details

Kelly Connor Business: EVERSANA Life Science Services LLC Email: kelly.connor@eversana.com Phone: (614) 5929652

Related Public Records

Same Entity

CYCLOMEDICA AUSTRALIA PTY LTD

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 8043631. Last updated year: 2026. Please use registration number 8043631 when referencing this establishment in official correspondence.