Benannt durch/Designated by Zentralstelle der Lander fur Gesundheitsschut2 bef Armelmirteln und j Medizinprodukten | EC Certificate Full Quality Assurance System Directive 93/42/EEC on Medical Devices (MDD), Annex II excluding (4) (Devices in Class lla, lib or III) Manufacturer: Roechling Medical Lancaster, LLC 44 Denver Rd Denver PA 17517 USA The Certification Body of T0V SOD Product Service GmbH declares that the aforementioned manufacturer has implemented a quality assurance system for design, manufacture and final inspection of the respective devices / device categories in accordance with MDD Annex II. This quality assurance system conforms to the requirements of this Directive and is subject to periodical surveillance. For marketing of class III devices an additional Annex II (4) certificate is mandatory. See also notes overleaf. Valid from: Valid until: /. Stefan Preili Head of Certification/Notified Body TOV SOD Product Service GmbH is Notified Body with identification no. 0123 TOV SOD Product Service GmbH • Certification Body • Ridlerstralie 65 • 80339 Munich • Germany

Benannt durch/Designated by Zentralstelle der Lander -o fur Gesuncheitsschutz bei Arzneimitteln und * Medi/inorodukten | Full Quality Assurance System Directive 93/42/EEC on Medical Devices (MDD), Annex II excluding (4) (Devices in Class lla, lib or III) Roechling Medical Lancaster, LLC 44 Denver Rd, Denver PA 17517, USA T0V SOD Product Service GmbH is Notified Body with identification no. 0123 TOV SClD Product Service GmbH • Certification Body • Ridlerstralie 65 • 80339 Munich • Germany ___®