Linus Health
United States US-MF-000024342 Last updated 21 Oct 2026
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- Devices
- 16
- Registries
- EUDAMEDGUDID
- FDA recalls
- 0
Catalogue
DCTclock 10039 Ref 10039
DCTclock 10041 Ref 10041
DCTclock 10003 Ref 10003
DCTclock 10005 Ref 10005
DCTclock 1110 Ref 1110
DCTclock 10015 Ref 10015
DCTclock 10072 Ref 10072
DCTclock 10006 Ref 10006
DCTclock 10093 Ref 10093
DCTclock 10004 Ref 10004
DCTclock 10096 Ref 10096
Core Cognitive Evaluation Ref 20002
Core Cognitive Evaluation Ref 20004
Core Cognitive Evaluation Ref 20001
Core Cognitive Evaluation Ref 20006
Core Cognitive Evaluation Ref 20005
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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.
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.
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.
Information
- Country
- United States
- Address
- 280, Summer Street, Boston, United States
- Website
- www.linushealth.com
- [email protected]
- Phone
- +1 617 433 1777
- PRRC contact
- Suj Shah
- EUDAMED SRN
- US-MF-000024342