List of medical devices given exceptional use authorisations
Updated 4 November 2024
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Manufacturer: Affymetrix, Inc (part of Thermo Fisher)
AxiomTM Total Blood Typing Solution/Gene Titan™ Multi-Channel Instrument System
Issue date: 9 August 2024
Expiry date: 9 February 2025
MHRA reference number: DEU/010/2023/002
Manufacturer: NHS Blood and Transplant
Integrated Analysis Package (IAP) software
Issue date: 9 August 2024
Expiry date: 9 February 2025
MHRA reference number: DEU/002/2024/002
Manufacturer: Joerns Healthcare Inc
Dolphin Fluid Immersion Simulation System
Issue date: 6 August 2024
Expiry date: 6 February 2025
MHRA reference number: DEU/011/2023/002
Manufacturer: Thora Tech GmbH
MONSOON high-frequency jet ventilator (Model 4): TT Laserjet catheters (40cm and 70cm), Y-piece for CO2 measurement, Test Lung
Issue date: 24 July 2024
Expiry date: 24 January 2025
MHRA reference number: DEU/005/2024/001
Manufacturer: Medtronic Inc/Medtronic Ltd
Cardiac Perfusion Procedure Packs - M443213F, M447708K and M449117G only.
Issue date: 28 June 2024
Expiry date: 20 December 2024
MHRA reference number: DEU/006/2024/001 - Extension issued
Manufacturer: BIRR BioSciences
BIRR BioSciences products
Issue date: 2 May 2024
Expiry date: 2 February 2025 - Extension issued
MHRA reference number: DEU/004/2024/002
Manufacturer: XVIVO Perfusion AB, Sweden
XVIVO (non-ischemic hypothermic perfusion) NIHP
Issue date: 22 April 2024
Expiry date: 29 April 2025 - Extension issued
MHRA reference number: DEU/001/2024/001
Manufacturer: Thora Tech GmbH
MONSOON high-frequency jet ventilator (Model 4)
Issue date: 6 March 2024
Expiry date: 24 January 2025 - Extension issued
MHRA reference number: DEU/011/2023/004
Manufacturer: Medgyn International Inc
Medgyn Word Bartholin Catheter, Medgyn Amniohook and Medgyn Post-partum balloon catheter
Issue date: 25 January 2024
Expiry date: 24 January 2025 - Extension issued
MHRA reference number: DEU/011/2023/001
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
Manufacturer: Smiths Medical ASD, Inc.
Pain Management Kits - Combined Spinal Epidural, Epidural, Peripheral Nerve Block and Spinal kits
Issue Date: 24 May 2024
Expiry Date: 24 November 2024 - Extension issued
MHRA reference number: DEU/011/2022/007
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: Integra Lifesciences Ltd
Licox Probes and Introducers
Issue Date: 14 June 2023
Expiry Date: 31 May 2024 - Extension issued
MHRA reference number: DEU/011/2022/003
Manufacturer: HeartWave Inc (Medtronic Ltd)
The Heartware HVAD (model number 1104) System
Issue Date: 26 March 2023
Expiry Date: 19 March 2025 - Extension issued
MHRA reference number: DEU/012/2022/006
Manufacturer: Integra Lifesciences Ltd
NeuroBalloon
Issue Date: 21 December 2022
Expiry date: 1 April 2025 - Extension issued
MHRA reference number: DEU/011/2022/002
Manufacturer: Becton, Dickinson & Company
BD BodyGuard™ Accessory Products - ‘Bolus Cable’
Issue Date: 3 November 2022
Expiry Date: 31 January 2025 - Extension issued
MHRA reference number: DEU/008/2022/015
Manufacturer: Edare Inc
Device/model name: Wireless Automated hearing Test System WAHTS AC1
Issue date: 8 February 2022
Expiry date: 9th January 2025 – Extension Issued
MHRA reference number: DEU/012/2021/002
Manufacturer: Becton, Dickinson & Company
Device/model name: BD BodyComm™
Issue date: 11 May 2022
Expiry Date: 31 January 2025 - Extension issued
MHRA reference number: DEU/004/2022/003
Manufacturer: BioAccess, Inc
Device model/name: MH-2150—Marrow Collection System
Issue Date: 6 October 2022
Expiry Date: 3 January 2025 - Extension issued
MHRA reference number: DEU/009/2022/005
Manufacturer: Edwards Lifesciences LLC
Device model/name: Atrioseptostomy Catheters
Issue Date: 1 June 2023
Expiry Date: 04 December 2024 - Extension issued
MHRA reference number: DEU/012/2022/024