Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011367240

FEI Number

3011367240

Entity Name

AXXIN PTY LTD

City/State/Country

Eaglemont Victoria, AU

Establishment Address

677 The Boulevard, Eaglemont Victoria 3084, AU

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Axxin Pty Ltd (Owner Number: 10072907)

Owner / Operator Contact Address

677 The Boulevard, Axxin, Eaglemont, AU-VIC 3084, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2020-05-04

Official Correspondent

No official correspondent registered.

US Agent Details

Nathan Butlin Business: Axxin Email: nathan.b@axxin.com Phone: (415) 6804980

Related Public Records

Same Entity

Axxin Pty Ltd

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
1318354	Trinity Biotech USA	Jamestown, NY, US
1524213	MERIDIAN BIOSCIENCE, INC.	Cincinnati, OH, US
2242436	ZEUS SCIENTIFIC LLC	BRANCHBURG, NJ, US
1924669	REMEL, INC.	LENEXA, KS, US
1122855	TECHLAB, INC.	BLACKSBURG, VA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011367240. Last updated year: 2026. Please use registration number 3011367240 when referencing this establishment in official correspondence.