NeuroCatch EPiO EPIO

GUDID G134EPIO1

NeuroCatch EPiO for use with the NeuroCatch Platform System.

NeuroCatch Inc

Electroencephalograph

• Primary Device ID: G134EPIO1
• NIH Device Record Key: 504b537e-ded7-490b-ad30-d8ad40c699af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroCatch EPiO
• Version Model Number: 2.0
• Catalog Number: EPIO
• Company DUNS: 203694427
• Company Name: NeuroCatch Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G134EPIO1 [Primary]

FDA Product Code

• PTY: Computerized Cognitive Assessment Aid, Exempt

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-10
• Device Publish Date: 2025-02-28

Devices Manufactured by NeuroCatch Inc

• G134EPIO1 - NeuroCatch EPiO: 2025-03-10NeuroCatch EPiO for use with the NeuroCatch Platform System.
• G134EPIO1 - NeuroCatch EPiO: 2025-03-10 NeuroCatch EPiO for use with the NeuroCatch Platform System.
• G134NCCPXS1 - NeuroCatch EEG Cap: 2024-12-09 NeuroCatch EEG Cap, size extra small for use with the NeuroCatch Platform System
• G134NCCPL1 - NeuroCatch EEG Cap: 2022-10-10 NeuroCatch EEG Cap, size Large for use with the NeuroCatch Platform system
• G134NCCPM1 - NeuroCatch EEG Cap: 2022-10-10 NeuroCatch EEG Cap, size Medium for use with the NeuroCatch Platform system
• G134NCCPS1 - NeuroCatch EEG Cap: 2022-10-10 NeuroCatch EEG Cap, size Small for use with the NeuroCatch Platform system
• G134NCCP1 - NeuroCatch Platform: 2022-09-02 EEG Cap used for the NeuroCatch Platform Sizes SML, MED, LRG.
• G134NCEB1 - NeuroCatch Platform: 2022-09-02 Earbuds used for the NeuroCatch Platform (REF NCP2)
• G134NCP21 - NeuroCatch Platform: 2022-09-02 NeuroCatch Platform system REF: NCP2