Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003617581

FEI Number

3003617581

Entity Name

MICROPACE PTY. LTD.

City/State/Country

Homebush West New South Wales, AU

Establishment Address

41/159 Arthur Street, Homebush West New South Wales 2140, AU

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

MICROPACE PTY. LTD. (Owner Number: 9044248)

Owner / Operator Contact Address

41/159 Arthur Street, Homebush West, AU-NSW 2140, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EPS320 CARDIAC STIMULATOR STIMCOR CARDIAC STIMULATOR SGU Replacement Spares for EPS320 Family ORLAB Cardiac Stimulator STIMLAB Cardiac Stimulator OneLINK Splitter Cable MedConnect Adaptor Cable EP Y Adaptor Cable

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOQ	Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)	Cardiovascular	Class 2	870.1750	2001-07-11
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2023-08-05

Official Correspondent

MICHAEL CEJNAR

US Agent Details

Michelle Le Business: Micropace EP, Inc. Email: m.le@micropaceep.com Phone: (714) 2587025

Related Public Records

Same Entity

MICROPACE 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 3003617581. Last updated year: 2026. Please use registration number 3003617581 when referencing this establishment in official correspondence.