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Cognigram

FDA UDI

Class II (US FDA UDI)

by Cogstate Ltd

Identity

Trade Name
Cognigram FDA UDI
Generic Name
Cause-and-effect assistive training device FDA UDI
Device Name
Cognigram is a self-administered digital medical device powered by Cogstate Brief Battery. It measures cognitive functions, processes data, and auto-generates comprehensive test reports. FDA UDI
Model / Reference
7.0.0 FDA UDI
Description
Cognigram is a self-administered digital medical device powered by Cogstate Brief Battery. It measures cognitive functions, processes data, and auto-generates comprehensive test reports. FDA UDI

Identifiers

Primary DI / UDI-DI
00860011464518 FDA UDI
FDA Product Code
PTY FDA UDI
GMDN Term
Cause-and-effect assistive training device FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1470 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

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cause-and-effect assistive training device

Cognigram by Cogstate Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cause-and-effect assistive training device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cogstate Ltd

Sources (1)

  • FDA UDI fb8d56ec-6dbf-478e-b63d-cea346468787 34 fields · synced May 30, 2026