List of medical devices given exceptional use authorisations
Updated 3 May 2024
Manufacturer: BIRR BioSciences
BIRR BioSciences products
Issue date: 2 May 2024
Expiry date: 2 August 2024
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: 31 October 2024
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: 31 July 2024
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: 25 July 2024
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: Medtronic Ltd
Permacol Surgical Implant
Issue date: 22 August 2023
Expiry date: 24 February 2024
MHRA reference number: DEU/001/2023/003
Manufacturer: Smiths Medical ASD, Inc.
Pain Management Kits - Combined Spinal Epidural, Epidural, Peripheral Nerve Block and Spinal kits
Issue Date: 14 August 2023
Expiry Date: 14 February 2024
MHRA reference number: DEU/011/2022/007
Manufacturer: Medtronic Ltd
Pocket Adaptor (model 64002) and Medical Adhesive Kit (080118)
Issue Date: 14 August 2023
Expiry Date: 24 February 2024
MHRA reference number: DEU/012/2022/021
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: Numed Inc
SPECIAL USE OF CP COVERED STENTS FOR TREATMENT OF SINUS VENOSUS ASD
Issue Date: 24 March 2021
Expiry Date: 31 October 2023
MHRA reference number: DEU/002/2021/001
Manufacturer: HeartWave Inc (Medtronic Ltd)
The Heartware HVAD (model number 1104) System
Issue Date: 26 March 2023
Expiry Date: 30 September 2024 - Extension issued
MHRA reference number: DEU/012/2022/006
Manufacturer: Integra Lifesciences Ltd
NeuroBalloon
Issue Date: 21 December 2022
Expiry date: 30 September 2024 - 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: 1 April 2024 - 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: 30 January 2024 – Extension Issued
MHRA reference number: DEU/012/2021/002
Manufacturer: Vygon GmbH
Device/model name: Catheters and other single use medical devices (various)
Issue date: 10 August 21
Expiry date: 31 May 2024 – Extension Issued
MHRA reference number: DEU/007/2021/003
Manufacturer: Becton, Dickinson & Company
Device/model name: BD BodyComm™
Issue date: 11 May 2022
Expiry Date: 25 July 2024 - 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: 4 June 2024 - 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: 27 May 2024 - Extension issued
MHRA reference number: DEU/012/2022/024
Manufacturer: Hunter Scientific Ltd (on behalf of BIRR Biosciences)
Device model/name: BIRR Biosciences Products
Issue Date: 21 March 2024
Expiry Date: 2 May 2024
MHRA reference number: DEU/011/2023/005
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