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Instructions for use

Table of contents​

These are the instructions for use of Legit.Health, a Class I medical device software under Council Directive 93/42/EEC. They describe what the device does, who it is intended for, how it is integrated into a care provider's system, and how it is to be used safely.

  1. Table of contents
  2. General information
    1. Label
    2. Intended use or purpose
    3. Technical specifications
    4. Maintenance
    5. Access
    6. UK market access and vigilance
  3. Installation manual
    1. Output
    2. Scoring systems
  4. Clinical user manual
    1. Important safety information
    2. How to take pictures
  5. Request paper instructions for use
  6. Need support?

Manufacturer and regulatory identification​

ItemDetails
ManufacturerAI Labs Group SL, BAT Tower, Gran Vía 1, 48001, Bilbao, Biscay, Spain. Telephone: 625752302. Email: support@legit.health
UK Responsible PersonAPOTECH CONSULTING LIMITED, 71-75 Shelton Street, London, WC2H 9JQ, England, United Kingdom
CE markingCE marking per Council Directive 93/42/EEC
Revision of these instructions for useDevice version 2.1. Date of issue or latest revision: 26 August 2026. Minor revision.
Electronic instructions for use

Due to the digital nature of this document, and the digital nature of the device itself, you are seeing the last published version at all times at https://ifu-eu-mdd.legit.health. You may download it as a PDF, but we recommend that you read this document in its digital version, because offline use is not the recommended method. This makes particular sense given that the device itself is cloud software and cannot be used without a device with internet access, which eliminates the risk of using the device without its instructions. A paper copy of these instructions for use can be requested at no additional cost, as described in Request paper instructions for use.