Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010805634

FEI Number

3010805634

Entity Name

Anteris Aus Operations Pty Ltd

City/State/Country

Malaga Western Australia, AU

Establishment Address

26 Harris Road, Malaga Western Australia 6090, AU

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Anteris Technology Corporation (Owner Number: 10046278)

Owner / Operator Contact Address

860 Blue Gentian Road, Suite 340, Eagan, MN 55121, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200566

PMA Number

N/A

All Registered Proprietary Names

ADAPT Tissue

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PSQ	Intracardiac Patch Or Pledget, Biologically Derived	Cardiovascular	Class 2	870.3470	2020-06-09

Official Correspondent

Renee Cveykus

US Agent Details

Renee Cveykus Business: Anteris Technologies Corporation Email: rcveykus@anteristech.com Phone: (651) 4930606

Related Public Records

Same Entity

Anteris Technology Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012664855	Anteris Technologies Corporation	Eagan, MN, US

Similar Registrations

Registration Number	Establishment Name	Location
3020856782	HELIOS CARDIO INC.	Natick, MA, US
1450662	Isomedix Operations, Inc.	Libertyville, IL, US
2183620	SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.)	Saint Paul, MN, US
1047843	ISOMEDIX OPERATIONS INC.	SPARTANBURG, SC, US
3012664855	Anteris Technologies Corporation	Eagan, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010805634. Last updated year: 2026. Please use registration number 3010805634 when referencing this establishment in official correspondence.