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

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

Product catalog summary
Certificate Overview: This document certifies that Oxylitre Holdings Limited, located at Morton House, Skerton Road, Old Trafford, Manchester, UK, holds a Quality Management System certificate compliant with ISO 13485:2016 and EN ISO 13485:2016 standards.
Scope of Certification: The certification covers the design, manufacture, inspection, repair, service, and supply of various medical devices including pressure regulators, pipeline flow meters, hoses and fittings, suction units, electrical mobile suction pumps, injector suction systems, portable battery suction pumps, Entonox demand systems for pain relief, and medical attachments/components.
Certification Details:
  • Certificate Number: MD 694747
  • Original Registration Date: January 8, 2019
  • Effective Date: September 29, 2022
  • Latest Revision Date: September 20, 2022
  • Expiry Date: September 28, 2025
Issuing Authority: The certificate is issued by BSI, represented by Graeme Tunbridge, Senior Vice President Medical Devices. It is an electronic certificate that can be authenticated online, with printed copies validated at the BSI website.
Contact Information: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP, UK. Phone: +44 345 080 9000.
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Catalog excerpts

Quality Managment System - ISO 13485:2016 & EN ISO 13485:2016-1

Certificate of Registration QUALITY MANAGEMENT SYSTEM - ISO 13485:2016 & EN ISO 13485:2016 This is to certify that: Oxylitre Holdings Limited Morton House Skerton Road, Old Trafford Manchester M16 0WJ United Kingdom Holds Certificate Number: and operates a Quality Management System which complies with the requirements of ISO 13485:2016 & EN ISO 13485:2016 for the following scope: Design, manufacture, inspection, repair, service and supply of, Pressure regulators, Pipeline flow meters, Pipeline hoses and fittings, Pipeline suction units and jar systems, Electrical mobile suction pumps, Injector suction systems, Portable battery suction pumps, Entonox demand systems for pain relief and Attachments/components for medical use. For and on behalf of BSI: Graeme Tunbridge, Senior Vice President Medical Devices Original Registration Date: 2019-01-08 Latest Revision Date: 2022-09-20 Expiry Date: 2025-09-28 Page: 1 of 1 This certificate was issued electronically and remains the property of BSI and is bound by the conditions of contract. An electronic certificate can be authenticated online. Printed copies can be validated at www.bsigroup.com/ClientDirectory Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 345 080 9000 BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK. A Member of the BSI Group of Companies.

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