* Medicines & Healthcare products Regulatory Agency Decision LIST OF MEDICAL DEVICES GIVEN EXCEPTIONAL USE AUTHORISATIONS Updated 30 May 2025 CONTENTS * Embody Orthopaedic Limited *

Southern Implants UK Ltd * Podopro UK Ltd * EBR Systems, Inc/EBR Systems (UK) Ltd * Manufacturer: OBP Medical corporation * Covidien LLC/Medtronic Ltd * Manufacturer: Greiner Bio-One GmbH *

Manufacturer: Affymetrix, Inc (part of Thermo Fisher) * Manufacturer: NHS Blood and Transplant * Manufacturer: Joerns Healthcare Inc * Manufacturer: Thora Tech GmbH * Manufacturer: BIRR B.V

* Manufacturer: XVIVO Perfusion AB, Sweden * Manufacturer: Medgyn International Inc * Manufacturer: Smiths Medical ASD, Inc. * Manufacturer: Integra Lifesciences Ltd * Manufacturer:

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/list-of-medical-devices-given-exceptional-use-authorisations

EMBODY ORTHOPAEDIC LIMITED H1 Instruments Issue date: 8 May 2025 Expiry date: 8 November 2025 MHRA reference number: DEU/001/2025/002 SOUTHERN IMPLANTS UK LTD Southern Implants

Osseointegrated Fixtures Implants Issue date: 17 March 2025 Expiry date: 17 September 2025 MHRA reference number: DEU/007/2023/001 PODOPRO UK LTD Swab-it Phenol swabs Issue date: 3 March

2025 Expiry date: 3 September 2025 MHRA reference number: DEU/001/2025/001 EBR SYSTEMS, INC/EBR SYSTEMS (UK) LTD Software upgrade (version 6.5.1 ) for use on the WiSE CRT System’s Model 5100

Programmer Issue date: 11 February 2025 Expiry date: 11 August 2025 MHRA reference number: DEU/012/2024/001 MANUFACTURER: OBP MEDICAL CORPORATION Single-use, sterile, lighted hand-held

surgical retractors Issue date: 11 February 2025 Expiry date: 11 August 2025 MHRA reference number: DEU/012/2024/002 COVIDIEN LLC/MEDTRONIC LTD Emprint Ablation Catheter CA108L1 Issue date:

14 February 2025 Expiry date: 30 April 2025 MHRA reference number: DEU/008/2024/001 MANUFACTURER: GREINER BIO-ONE GMBH HOLDEX ® Single-Use Holder PP, VACUETTE ® SAFELINK, VACUETTE ® Luer

Adapter, VACUETTE ® Multiple Use Drawing Needle, VACUETTE ® VISIO PLUS Needle, SAFETY Blood Collection sets, Blood Collection sets, VACUETTE ® QUICKSHIELD Complete, VACUETTE ® QUICKSHIELD

Complete PLUS, VACUETTE ® EVOPROTECT SAFETY Blood Collection Sets Issue date: 10 January 2025 Expiry date: 10 July 2025 MHRA reference number: DEU/012/2024/003 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: 7 August 2025 - Extension issued MHRA reference

number: DEU/010/2023/002 MANUFACTURER: NHS BLOOD AND TRANSPLANT Integrated Analysis Package (IAP) software Issue date: 9 August 2024 Expiry date: 7 August 2025 Extension issued MHRA

reference number: DEU/002/2024/002 MANUFACTURER: JOERNS HEALTHCARE INC Dolphin Fluid Immersion Simulation System Issue date: 6 August 2024 Expiry date: 27 August 2025 - Extension issued 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: 23 July 2025 MHRA reference number: DEU/005/2024/001 EXTENSION ISSUED MANUFACTURER: BIRR B.V BIRR BioSciences products Issue date: 2 May 2024

Expiry date: 30 April 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 October 2025 - Extension issued MHRA reference number: DEU/001/2024/001 MANUFACTURER: MEDGYN INTERNATIONAL INC Medgyn Word Bartholin Catheter and Medgyn Amniohook

Issue date: 28 June 2024 Expiry date: 28 July 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: 20 November 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: 21 September 2025 - Extension issued MHRA reference number: DEU/011/2022/003 MANUFACTURER:

HEARTWARE INC The Heartware HVAD (model number 1104) System Issue Date: 26 March 2023 Expiry Date: 20 September 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: 10 October 2025 - Extension issued MHRA reference number: DEU/008/2022/015 MANUFACTURER:

CAESAREA MEDICAL ELECTRONICS LTD / BECTON, DICKINSON U.K. LIMITED Device/model name: BD BodyComm™ Issue date: 11 May 2022 Expiry Date: 20 August 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: 23 June 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: 29 November 2025 - Extension

issued MHRA reference number: DEU/012/2022/024 Back to top