Nurochek-Pro Application

Primary DI
09357225002021
Brand
Nurochek-Pro Application
Company
HEADSAFE MFG PTY LTD
Model
Nurochek-Pro Application (HS03-303)
Device description
The Nurochek-Pro Application (app) Software is a Windows desktop application that acts as the primary graphical user interface (GUI) for the user to control and communicate with the Nurochek-Pro Headset (HS03-267); both of which are components of the Nurochek-Pro System (HS03-369).
Published
2025-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OMCReduced- Montage Standard Electroencephalograph
PIWBrain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMCReduced- Montage Standard ElectroencephalographNeurology2
PIWBrain Injury Adjunctive Interpretive Electroencephalograph Assessment AidNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243426000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243426000Nurochek-Pro SystemHeadsafe Mfg Pty, Ltd.2025-03-27PIW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09357225002021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09357225002021093572250020219357225002021

GMDN Terms#

Term, Definition table
TermDefinition
Evoked-potential graphic recording systemAn assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from the sensory organs, or within the central nervous system. It typically includes a sensory stimulator/stimulation system and a graphic recorder. The characteristics of the recorded potential vary with recording location, stimulus modality and level, and level of consciousness or anaesthesia. The resultant waveform may be used to assess the function and integrity of the brain and its sensory pathways.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+61413133492support@team.headsafe.com

Regulatory Flags#

DUNS number
748905226
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09357225002014Nurochek-Pro Headset Nurochek-Pro Headset Assembly (HS03-267)HS03-2672026-03-18
09357225001017Nurochek-Pro Headset Nurochek-Pro Headset Assembly (HS03-267)HS03-2672025-12-15
09357225000041Nurochek-ProNurochek-Pro Kit (HS03-369) rev 2HS03-3692026-01-23
09357225000034Nurochek-ProNurochek-Pro Kit (HS03-369) rev 1HS03-3692025-12-15
09357225002038Nurochek-Pro ServerNurochek-Pro Server (HS03-304)HS03-3042025-12-15
09357225003028Nurochek-Pro Soft Sensor KitNurochek-Pro Soft Sensor Kit (HS03-313)HS03-3132025-12-15
09357225006029Nurochek-Pro Saline SolutionSaline Solution Bottle Assembly (HS03-368)HS03-3682025-12-15

Other Devices Sharing Product Codes#

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Primary DIBrandCompanyProduct codePublished
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05999860882053QUEX SQX WORLD LTDOMC2026-04-27
05999860882060QUEX EDQX WORLD LTDOMC2026-04-27
05999860882077QUEX SQX WORLD LTDOMC2026-04-27
B566847020ZmachineGeneral SleepOMC2026-04-16
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyOMC2026-04-15
B566847001ZmachineGeneral SleepOMC2026-04-09
B566847002ZmachineGeneral SleepOMC2026-04-09
09357225002014Nurochek-Pro HeadsetHEADSAFE MFG PTY LTDPIW2026-03-18
09357225002014Nurochek-Pro HeadsetHEADSAFE MFG PTY LTDOMC2026-03-18
09342451002655Compumedics SomfitCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002662Compumedics SomfitCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002747Compumedics FalconCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002754Compumedics FalconCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002785Compumedics FalconCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002822Compumedics SomfitCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002860Compumedics SomfitCOMPUMEDICS LIMITEDOMC2026-03-12
09342451007063Compumedics Somfit DCOMPUMEDICS LIMITEDOMC2026-03-12
09357225000041Nurochek-ProHEADSAFE MFG PTY LTDPIW2026-01-23
09357225000041Nurochek-ProHEADSAFE MFG PTY LTDOMC2026-01-23
00850063034364Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2025-12-22
09357225000034Nurochek-ProHEADSAFE MFG PTY LTDPIW2025-12-15
09357225000034Nurochek-ProHEADSAFE MFG PTY LTDOMC2025-12-15
09357225001017Nurochek-Pro HeadsetHEADSAFE MFG PTY LTDOMC2025-12-15
09357225001017Nurochek-Pro HeadsetHEADSAFE MFG PTY LTDPIW2025-12-15
09357225002038Nurochek-Pro ServerHEADSAFE MFG PTY LTDOMC2025-12-15
09357225002038Nurochek-Pro ServerHEADSAFE MFG PTY LTDPIW2025-12-15
09357225003028Nurochek-Pro Soft Sensor KitHEADSAFE MFG PTY LTDOMC2025-12-15
09357225003028Nurochek-Pro Soft Sensor KitHEADSAFE MFG PTY LTDPIW2025-12-15