Headsafe Mfg Pty, Ltd.
AustraliaFDA applicant, unverified FDA
- Devices
- 10
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Headsafe Mfg Pty, Ltd. makes
Headsafe Mfg Pty, Ltd. manufactures the Nurochek-Pro System and the Nurochek-II System, which are designed for neurological monitoring and diagnostic purposes in clinical settings. These systems appear to provide real-time or continuous assessment of neurological function, likely used in critical care or intraoperative environments to support patient safety and treatment decisions.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the 510(k) clearance registry. These devices are intended for use within the United States, adhering to the regulatory framework governing their performance, safety, and compliance standards.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Nurochek-Pro System Ref K243426
Regimes: 510(k) Registry: 510(k)Nurochek-II System Ref K231914
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 748905226
- [email protected]
- Phone
- +61413133492
FDA establishments
- Headsafe Mfg Pty Ltd Surry Hills New South Wales · AU FEI 3018238599
Frequently asked questions
How many devices does Headsafe Mfg Pty, Ltd. have in the registry?
The registry currently lists 10 devices for Headsafe Mfg Pty, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Headsafe Mfg Pty, Ltd.'s devices?
Among its 10 most recently registered devices, Headsafe Mfg Pty, Ltd. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (8 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Headsafe Mfg Pty, Ltd.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Headsafe Mfg Pty, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Headsafe Mfg Pty, Ltd. in the registry?
The most recently registered devices listed for Headsafe Mfg Pty, Ltd. include Nurochek-Pro Kit (HS03-369) rev 1, Nurochek-Pro Headset Assembly (HS03-267), Nurochek-Pro Kit (HS03-369) rev 2 and Nurochek-Pro Application (HS03-303).
Which FDA establishments are linked to Headsafe Mfg Pty, Ltd.?
1 FDA establishment is linked to Headsafe Mfg Pty, Ltd. in the registry; they are listed on the company page.