Data / Medical devices / Australia / Headsafe MFG Pty Ltd
Headsafe MFG Pty Ltd: FDA-registered device maker in Surry Hills New South Wales, Australia, 1 510(k) clearance
Headsafe MFG Pty Ltd is registered with the FDA (registration 3018238599) in Surry Hills New South Wales, Australia. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 27, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018238599
- Address
- 61 Marlborough St Suite 76, Surry Hills New South Wales, Australia, 2010
- Owner or operator
- Headsafe Holdings, Inc. (10081128)
- Roles
- Manufacturer
- First device listed
- August 1, 2025
- Registered through
- 2026
- Brand names listed
- Nurochek, Nurochek-Pro, Nurochek-Pro System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid | PIW | 2 | Manufacturer | accessdata.fda.gov |
| Reduced- Montage Standard Electroencephalograph | OMC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 27, 2025 | K243426 | Nurochek-Pro System | PIW | Substantially Equivalent | Headsafe Mfg Pty, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 27, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.