CERTIFICAT UE D’ASSURANCE QUALITE DE LA PRODUCTION Reglement (UE) 2017/745, Annexe XI Partie A EU PRODUCTION QUALITY ASSURANCE CERTIFICATE Regulation (EU) 2017/745, Annex XI Part A Delivre Ie/Issued on: July 1st, 2024 Zl Athelia III - 96 Voie Atlas 13600 LA CIOTAT FRANCE SRN: FR-MF-000000671 GMED atteste qu’a I’examen des resultats figurant dans le(s) rapport(s) d’audit du systeme de gestion de la qualite et le(s) rapport(s) devaluation de la documentation technique associe(s), le cas echeant, reference(s) P607293, le systeme de gestion de la qualite est conforme aux dispositions pertinentes du reglement (UE) 2017/745 pour les produits suivants : GMED certifies that, on the basis of the results listed in the quality management system audit report(s) and the associated technical documentation assessment report, where appropriate, referenced P607293, the quality management system complies with the relevant provisions of the regulation (EU) 2017/745 for the following products: Bio-lmpedancemetre. Bio-impedance measuring device. Voir details sur addendum / See addendum for additional information Aux fins de la mise sur le marche de dispositifs de classe III et/ou de dispositifs de classe lib implantables a I'exception des sutures, agrafes, produits d'obturation dentaire, appareils orthodontiques, couronnes dentaires, vis, cales, plaques, guides, broches, clips et dispositifs de connexion, un autre certificat delivre conformement aux dispositions du reglement (UE) 2017/745 est requis. La validite du present certificat est conditionnee au respect des obligations qui decoulent du systeme de gestion de la qualite approuve et de la surveillance effectuee par I’organisme notifie prevue par le reglement. Ce certificat est lie par les conditions du contrat. For the purpose of placing on the market class III devices and / or class lib implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, another certificate issued in accordance with the provisions of the regulation (EU) 2017/745 is required. The validity of this certificate is subject to compliance with the obligations arising from the approved quality management system and from the surveillance carried out by the notified body as required by the regulation. This certificate is bound by the conditions of the contract. Debut de validite /Effective date: July 1 st, 2024 (included) Valable jusqu'au /Expiry date: June 30th, 2029 (included) GMED • Societe par Actions Simplifiee au capital de 300 000 € • RCS Paris 839 022 522 • Organisme Notifie/Notified Body n° 0459 Siege social: 1, rue Gaston Boissier - 75015 Paris • Tel.: 0140 43 37 00 • lne-gmed.com