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Morton House Skerton Road Manchester M16 0WJ +44 (0)161 872 6322 sales@oxylitre.co.uk service@oxylitre.co.uk
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Our Standards & Accreditations

    Standards & Accreditations

    A pioneer for medical device quality

    Oxylitre is accredited to ISO 13485:2016, ISO 9001, & Directive 93/42/EEC Please click on the tabs below to view the relevant certification.

    Oxylitre is also proudly compliant to the Waste Electrical & Electronic Regulations 2013
    WEEE Account No: 331230.
    WeeCare Plc: help line no: 0330 331 1801
    WEEE Certificate No: WEE/MM4847AA

    Medical Device Directive

    ISO 13485

    ISO 9001

    Waste Electrical & Electronic Regulations 2013
    Oxylitre EC certificate issued by the notified body

    Medical Device Directive

    Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4

    Download

    Extension Letter
    Oxylitre ISO 13485 quality management system certificate

    EN ISO 13485:2016

    Quality Management System - ISO 13485:2016 & EN ISO 13485:2016

    Download
    Oxylitre ISO 9001 quality management system certificate

    ISO 9001:2015

    Quality Management System - ISO 9001:2015

    Download
    Oxylitre WEEE producer compliance certificate for 2024

    Waste Electrical & Electronic Regulations 2013

    Waste Electrical & Electronic Regulations 2013

    Download

    Legal manufacturer: Oxylitre Holdings Limited, Morton House, Skerton Road, Old Trafford, Manchester M16 0WJ, United Kingdom. Quality management system certified to ISO 13485:2016 & ISO 9001:2015. CE marked under Directive 93/42/EEC.

    CE 93/42/EEC Accreditations IFU & symbols

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