EU MDR Article 120 extension confirmation • the CE certificate(s) listed below were issued under the EU Medical Devices Directive (93/42/EEC) or under the EU Active Implantable Medical Devices Directive (90/385/EEC) on or after 25 May 2017 and were still valid on 26 May 2021 AND • the conditions for extension of the validity of the CE certificate(s) (under the EU Medical Devices Regulation (2017/745) (EU MDR) Article 120) set out below have been met in relation to the CE certificates as listed in the table below

[Complete the relevant table below] David Fletcher Business Manager 10 June 2024 Name of Signatory Position of Signatory Date

Business Stream Products Certification Department LGAI� Precisely Right. TOV Rheinland LGA Products GmbH • 51105 Koln AHT Holdings Ltd. Unit A 1 Gildersome Spur, Morley, Leeds West Yorkshire LS27 7JZ UNITED KINGDOM Contact Tel. +49 911 655-5225 Mail: medical [email protected] Date May 16, 2024 Notified Body Confirmation Letter Reference. : PLA-HZ-2024-05-10 To whom it may concern, Confirmation of the status of a formal application, written agreement, and appropriate surveillance in the framework of Regulation EU 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional...

The transition timelines that apply to the devices covered by this letter, subject to the manufacturer’s continued compliance to the other conditions specified in Article 120.3c of MDR (as amended by (EU) 2023/607), are shown below: • May 26, 2026 for Class 111 custom-made implantable devices • December 31,2027 for Class Ill devices and Class llb implantable devices excluding Well-established technologies (WET - sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors) • December 31,2028 for other Class Ilb devices, Class I la,...

Production Quality Assurance Directive 93/42/EEC on Medical Devices, Annex V Holme Street Liversedge West Yorkshire WF15 6JF United Kingdom Active pressure care mattresses for prevention and treatment of pressure ulcers Jarostaw Pyclik TOV Rheinland LGA Products GmbH Tillystrafte 2 ■ 90431 Nurnberg ■ Germany TUV Rheinland LGA Products GmbH is a Notified Body according to Directive 93/42/EEC concerning medical devices with the identification number 0197. <0/020 h 04,08 ® TUV, TUEV and TUV are registered trademarks. Utilisation and application requires prior approval.