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QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
      • Annex 1 Responsibility matrix
      • Deprecated
      • Templates
        • T-001-001 Control of documents
        • T-001-002 Manufacturer declaration of conformity
        • T-001-005 List of external documents
        • T-001-006 IFU and label validation YYYY_nnn
        • T-001-007 Manufacturer declaration of conformity_MDR
        • T-001-008 _Device name_ label YYYY_nnn
        • T-001-009 Training on procedures of the QMS
      • Specific procedures
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-008 Product requirements
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, Redesign and Development
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation plan
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Cybersecurity
    • GP-025 Corporate Governance
    • GP-026 Product requirements for US market
    • GP-027 Product requirements for UK market
    • GP-028 Product requirements for the Brazilian market
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
    • GP-200 Remote Data Acquisition in Clinical Investigations
  • Records
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Procedures
  • GP-001 Control of documents
  • Templates
  • T-001-008 _Device name_ label YYYY_nnn

T-001-008 Device name label YYYY_nnn

Label​

  • Device name:
  • European Medical Device Nomenclature (EMDN) coding:
  • Global Medical Device Nomenclature (GMDN) coding:
  • Risk Classification according to EU MDR 2017/745:
SymbolMeaningInformation
drawingUnique Device Identifier(01)UDI-DI(10)n.n(11)YYYYMMDD
drawingVersion(10) n.n
drawingManufacture date(11) YYYYMMDD
drawingManufacturerAI Labs Group SL
BAT Tower, Gran Vía 1, 48001, Bilbao, Biscay (Spain)
drawingAuthorised representative in CountryAuthorised representative's name and address
SymbolMeaning
drawing
eIFU		Read the instructions before use
drawingIn case of observing an incorrect operation of the software, notify the manufacturer as soon as possible: support@ legit.health. The manufacturer will proceed accordingly. Any serious incident should be reported to AI Labs Group S.L. as well as to the National Competent Authority of the country.
drawing
DRAFT		EU MDR 2017/745 CE marking (DRAFT)
drawingMedical Device

Undesirable side-effects

It is not known or foreseen any undesirable side-effects specifically related to the use of the software.

Intended purpose​

Add intended purpose here

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: Team members involved
  • Reviewer: JD-003, JD-004
  • Approver: JD-001
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T-001-007 Manufacturer declaration of conformity_MDR
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T-001-009 Training on procedures of the QMS
  • Label
  • Intended purpose
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)