Decision

List of medical devices given exceptional use authorisations

Updated 10 December 2024

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: Smiths Medical ASD, Inc.

Pain Management Kits - Combined Spinal Epidural, Epidural, Peripheral Nerve Block and Spinal kits

Issue Date: 14 August 2023

Expiry Date: 27 May 2025 - Extension issued

MHRA reference number: DEU/011/2022/007

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: 9 June 2025 - Extension issued

MHRA reference number: DEU/012/2022/024