Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009433026

FEI Number

3009433026

Entity Name

SRXGLOBAL (AUSTRALIA) PTY LTD

City/State/Country

Dandenong Victoria, AU

Establishment Address

8-10 Kitchen Road, Dandenong Victoria 3175, AU

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SRXGlobal (Australia) Pty Ltd (Owner Number: 10046202)

Owner / Operator Contact Address

8-10 Kitchen Road, Dandenong, AU-VIC 3175, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GYDER® Hip System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-07-21

Official Correspondent

Divya Vinayachandran

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@UL.com Phone: (512) 3279997

Related Public Records

Same Entity

SRXGlobal (Australia) Pty Ltd

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

Similar Registrations

Registration Number	Establishment Name	Location
3002743211	NORTHERN DIGITAL, INC.	WATERLOO Ontario, CA
3016050940	Olive Branch Distribution Center	Olive Branch, MS, US
3020983478	ORTHOKEY ITALIA SRL	Firenze, IT
3014725904	Medtronic Medical Costa Rica S.R.L.	Coyol Alajuela, CR
3018405359	A7 INTEGRATION	Granby Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009433026. Last updated year: 2026. Please use registration number 3009433026 when referencing this establishment in official correspondence.