HEADSAFE MFG PTY LTD

FDA Device Registration & Listing · Surry Hills New South Wales, AU · Registration 3018238599

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3018238599
FEI Number
3018238599
Entity Name
HEADSAFE MFG PTY LTD
City/State/Country
Surry Hills New South Wales, AU
Establishment Address
61 Marlborough St, Suite 76, Surry Hills New South Wales 2010, AU
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Headsafe MFG Pty Ltd (Owner Number: 10081128)
Owner / Operator Contact Address
231 Birrell St, Bronte, AU-NSW 2024, AU
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K243426
PMA Number
N/A

All Registered Proprietary Names

Nurochek-Pro System Nurochek Nurochek-Pro

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PIW Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid Neurology Class 2 882.1450 2025-08-01
OMC Reduced- Montage Standard Electroencephalograph Neurology Class 2 882.1400 2025-08-01

Official Correspondent

No official correspondent registered.

US Agent Details

Jonathan Gimbel Business: RQM+ Email: JGimbel@rqmplus.com Phone: (724) 7138756

Related Public Records

Same Entity

Headsafe MFG 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 3018238599. Last updated year: 2026. Please use registration number 3018238599 when referencing this establishment in official correspondence.
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