List of medical devices that are no longer covered by an exceptional use authorisation
Updated 10 December 2024
© Crown copyright 2024
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: [email protected].
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/medical-devices-given-exceptional-use-authorisations-during-the-covid-19-pandemic/list-of-medical-devices-that-are-no-longer-covered-by-an-exceptional-use-authorisation
Medical devices that are no longer covered by an exceptional use authorisation are listed below.
Manufacturer: Getinge Ltd Maquet Cardiopulmonary GmbH
Extra Corporeal Membrane Oxygenation (ECMO) items produced by Getinge (HLS Set Advanced, the HIT Set Advanced and the PLS Sets)
Issue date: 25 March 2024
Expiry date: 30 September 2024 - extension issued
MHRA reference number: DEU/012/2023/002
Getinge (on behalf of Maquet Cardiopulmonary GmbH)
HLS and PLS sets
Issue Date: 25 March 2024
Expiry Date: 30 September 2024 - Extension issued
MHRA reference number: DEU/004/2023/003
Manufacturer: Inspire Medical Systems, Inc.
Device model/name: Hypoglossal Nerve Stimulation System Leads Stimulation Lead model number 4063 and Sense Lead model number 4340
Issue Date: 26 March 2024
Expiry Date: 26 September 2024
MHRA reference number: DEU/001/2024/001