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Linus Health

United States US-MF-000024342 Last updated 21 Oct 2026

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Devices
16
Registries
EUDAMEDGUDID
FDA recalls
0

Catalogue16

Authorised representatives

About

Linus Health is dedicated to transforming brain health for people across the world by advancing how we detect, diagnose, and address cognitive and brain disorders.

From the manufacturer's own website. Source

What Linus Health makes

The company produces devices for analyzing cognitive function through drawing-based tests, including repeated iterations of the DCTclock and a tool called the Core Cognitive Evaluation. These tools are designed to assess cognitive abilities via structured drawing tasks and standardized assessments.

The portfolio includes devices classified as Class I and Class II under regulatory frameworks, with listings in the EU’s EUDAMED database and the FDA’s UDI system. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Linus Health manufacture?

Linus Health specializes in devices that analyze cognitive function through drawing-based tests. The most common category is the drawing-test cognitive function analysis device, which includes repeated iterations of the DCTclock and a tool called the Core Cognitive Evaluation. These tools are designed to assess cognitive abilities by evaluating structured drawing tasks and standardized assessments.

Where is Linus Health based, and what regulatory databases list its devices?

Linus Health is based in the United States. Its devices are listed in two key regulatory databases: the EU’s EUDAMED system and the FDA’s Unique Device Identifier (UDI) database. These listings help ensure transparency and traceability of its products under applicable regulatory frameworks.

How are Linus Health’s devices classified under regulatory standards?

Linus Health’s devices fall into two primary regulatory classes: Class I and Class II. Classification depends on factors like risk level, intended use, and potential impact on patient safety. For example, cognitive assessment tools like the DCTclock and Core Cognitive Evaluation may be categorized differently based on their complexity and the level of intervention they require.

What is the purpose of the devices manufactured by Linus Health?

The devices from Linus Health are primarily used for detecting and diagnosing cognitive and brain disorders by analyzing cognitive function through structured drawing tasks. Tools like the DCTclock and Core Cognitive Evaluation help clinicians assess memory, attention, and executive function in a standardized way, supporting early intervention and treatment planning.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
United States
Address
280, Summer Street, Boston, United States
Phone
+1 617 433 1777
PRRC contact
Suj Shah
EUDAMED SRN
US-MF-000024342