Quality Management System REGULATION (EU) 2017/745 on Medical Devices Annex IX Chapter I, Section 2 and 3 and Chapter III EUDAMED Single Registration No.: Products: Z12050101 - STRESS ANALYSIS SYSTEMS Z12050192 - STRESS ANALYSIS INSTRUMENTS -MEDICAL DEVICE SOFTWARE Z12050301 - GENERAL PURPOSE ELECTROCARDIOGRAPHS Z12050403 - ECG HOLTER RECORDERS Z12050404 - BLOOD PRESSURE HOLTER RECORDERS Z12050492 - HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS -MEDICAL DEVICE SOFTWARE Z12059009 - ECG DATA MANAGEMENT SYSTEMS Z12150101 - CLINICAL/DIAGNOSTIC SPIROMETERS Z12150185 - SPIROMETRY INSTRUMENTS CONSUMABLES The Notified Body hereby declares that the requirements of Annex IX, Chapter I, Section 2 and 3 of the REGULATION (EU) 2017/745 have been met for the listed products. The above named manufacturer has established and applies a quality management system, which is subject to periodic surveillance, defined by Annex IX, Chapter I, Section 3 of the aforementioned regulation. The requirements of Annex IX, Chapter III are fulfilled. If class III devices or class IIb implantable devices referred to in the second subparagraph of Article 52(4) are covered by this certificate an EU technical documentation assessment certificate according to Chapter II, Section 4.9 is required before placing them on the market. Report No.: Effective date: Expiry date: Issue date: This certificate can be validated on https://www.certipedia.com Jaroslaw Pyclik TUV Rheinland LGA Products GmbH TillystraGe 2 • 90431 Nurnberg • Germany TUV Rheinland LGA Products GmbH is a Notified Body according to REGULATION (EU) 2017/745 concerning medical devices with the identification number 0197. ® TUV, TUEV and TUV are registered trademarks. Utilisation and application requires prior approval. Benannt durch/Designated by A Zentralstelle der Lander ^ fur Gesundheitsschutz i? bei Arzneimitteln und g Medizinprodukten | TUVRheinland® Precisely Right.

Quality Management System REGULATION (EU) 2017/745 on Medical Devices Annex IX Chapter I, Section 2 and 3 and Chapter III ASPEL S.A. os. H. Sienkiewicza 33 32-080 Zabierzow Poland EUDAMED Single Registration No.: Z129003 - CYCLES FOR PHYSIOTHERAPY AND/OR DIAGNOSTIC USES Z129006 - TREADMILLS FOR PHYSIOTHERAPY AND/OR DIAGNOSTIC USES Authorized representative(s): Not applicable Certificate history Report No.: Effective date: Expiry date: Issue date: This certificate can be validated on https://www.certipedia.com Jarostaw Pyclik TUV Rheinland LGA Products GmbH TillystraGe 2 • 90431 Nurnberg • Germany...