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Cumulus Functional Neurophysiology Platform

FDA UDI

Class II (US FDA UDI)

by Cumulus Neuroscience Limited

Identity

Trade Name
Cumulus Functional Neurophysiology Platform FDA UDI
Generic Name
Electroencephalographic electrode cap, reusable FDA UDI
Device Name
Cumulus EEG Headset and Mobile Application FDA UDI
Model / Reference
CN-T5H FDA UDI
Description
Cumulus EEG Headset and Mobile Application FDA UDI

Identifiers

Catalog Number
CN-T5H FDA UDI
Primary DI / UDI-DI
05061027610011 FDA UDI
510(k) Number
K221963 FDA UDI
FDA Product Code
GWQ FDA UDI
GMDN Term
Electroencephalographic electrode cap, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electroencephalographic electrode cap, reusable

Cumulus Functional Neurophysiology Platform by Cumulus Neuroscience Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electroencephalographic electrode cap, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cumulus Neuroscience Limited

Sources (1)

  • FDA UDI 3b1714c1-aba5-4759-ab86-42809b7150da 37 fields · synced May 30, 2026