CERTIFICATO CE. Dichiarazione di approvazione del sistema qualità (Sistema completo di garanzia qualità) Certificato n. 1924/MDD GT MEDICAL S.L.

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1 CERTIFICATO CE Certificato n. 1924/MDD Dichiarazione di approvazione del sistema qualità (Sistema completo di garanzia qualità) Visto l'esito delle verifiche condotte in conformità all'allegato II, con l'esclusione del punto 4, della direttiva 93/42/CEE e s.m.i., si dichiara che la ditta: GT MEDICAL S.L MADRID - C/LUIS I 94, 2 Planta Local 8 (ESP) - Spain mantiene negli stabilimenti di: MADRID - Camino de Hormigueras 122bis,3 Pl. P1-P2 (ESP) - Spain un sistema qualità che assicura la conformità dei seguenti prodotti: curativi e accessori protesici Viti cilindriche e protesiche dentali serie e modelli indicati in Allegato ai requisiti essenziali della direttiva suddetta ad essi applicabili (in tutte le fasi dalla progettazione al controllo finale) ed è sottoposta alla sorveglianza prevista dal punto 5 dell'allegato II. Riferimento pratiche IMQ: DM15A Questa Dichiarazione di approvazione è rilasciata dall'imq S.p.A. quale organismo notificato per la direttiva 93/42/CEE e s.m.i. Il numero identificativo dell'imq S.p.A. quale organismo notificato è: Emesso il: Data Scadenza: IMQ Questa Dichiarazione di approvazione è soggetta alle condizioni previste dall'imq nel "Regolamento per la certificazione CE dei dispositivi medici in base alla direttiva 93/42/CEE".

2 CERTIFICATO CE Certificato n. 1924/MDD Allegato Modd. Rif. Documento "LISTADO DE REFERENCIA AT003 ed. 01 del 20/09/2016"; valido solo se provvisto del timbro IMQ Marca GT MEDICAL curativi Modd. RIf. Documento "LISTADO DE REFERENCIA AT002 ed. 01 del 20/09/2016"; valido solo se provvisto del timbro IMQ. Marca GT MEDICAL e accessori protesici Modd. Rif. Documento : "LISTADO DE REFERENCIA AT004 ed. 01 del 20/09/2016"; valido solo se provvisto del timbro IMQ. Marca GT MEDICAL Viti cilindriche e protesiche dentali Modd. Rif. Documento "LISTADO DE REFERENCIA AT001 ed. 01 dated 20/09/2016"; valido solo se provvisto del timbro IMQ. Marca GT MEDICAL Emesso il: Data Scadenza: IMQ

3 EC CERTIFICATE Certificate No 1924/MDD Full Quality Assurance System Approval Certificate On the basis of our examination carried out according to Annex II, excluding section 4, of the Directive 93/42/EEC and its revised version, we hereby certify that: GT MEDICAL S.L MADRID - C/LUIS I 94, 2 Planta Local 8 (ESP) - Spain manages in the factories of: MADRID - Camino de Hormigueras 122bis,3 Pl. P1-P2 (ESP) - Spain a quality assurance system ensuring the conformity of the following products: Healing abutment s and prosthetic accessories Screws and dental prosthetic series and type refs in the Annex with the relevant essential requirements of the aforementioned directive (from design to final inspection and testing) and it is subject to surveillance as specified in section 5 of Annex II. Reference to IMQ files Nos: DM15A This Approval Certificate is issued by IMQ S.p.A. as Notified Body for the Directive 93/42/EEC and its revised version. Notified Body notified to European Commission under number: Date: Expirying Date: IMQ This Approval Certificate is subjected to the provisions laid down in the Rules for managing the EC Certification of Medical Devices on the basis of the Directive 93/42/EEC. This is a translation of the Italian text, which prevails in case of doubts

4 EC CERTIFICATE Certificate No 1924/MDD Annex Type ref. Ref. Document "LISTADO DE REFERENCIA AT003 ed. 01 dated 20/09/2016"; valid only if provided with IMQ stamp. Trade mark GT MEDICAL Healing abutment Type ref. Ref. Document "LISTADO DE REFERENCIA AT002 ed. 01 dated 20/09/2016"; valid only if provided with IMQ stamp. Trade mark GT MEDICAL s and prosthetic accessories Type ref. Ref. Document "LISTADO DE REFERENCIA AT004 ed. 01 dated 20/09/2016"; valid only if provided with IMQ stamp. Trade mark GT MEDICAL Screws and dental prosthetic Type ref. Ref. Document "LISTADO DE REFERENCIA AT001 ed. 01 dated 20/09/2016"; valid only if provided with IMQ stamp. Trade mark GT MEDICAL Date: Expirying Date: IMQ This is a translation of the Italian text, which prevails in case of doubts

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8 Your ref: --- Our ref: FP-0796/17-cs10 Date: Attention: Sara Sánchez Taberné GT MEDICAL S.L. C/LUIS I 94, 2 Planta Local MADRID ES Spain Dear Sirs Full Quality Assurance System Approval Certificate No 1924/MDD With reference to your application we inform you that, on the basis of checks carried out, we ascertain that the quality system of your factory meets the requirements according to Section 3.2 of the Annex II of Directive 93/42/EEC and its revised version (Directive 2007/47/CE), as regards the products specified below. We are therefore sending you herewith the Approval Certificate in object, in electronic form, in Italian and English language, as full quality assurance system declaration. As foreseen by the legislation the validity of such documents is guaranteed by the digital signature. In order to verify the details of the Certificate of Signature, please refer to the Guida alla verifica della firma digitale ( Guide to the digital signature ) on our website Yours sincerely, IMQ S.p.A. Product Department Manager Fulvio Giorgi Type ref. Ref. Document "LISTADO DE REFERENCIA AT003 ed. 01 dated 20/09/2016" Healing abutment Type ref. Ref. Document "LISTADO DE REFERENCIA AT002 ed. 01 dated 20/09/2016" s and prosthetic accessories Type ref. Ref. Document "LISTADO DE REFERENCIA AT004 ed. 01 dated 20/09/2016" Screws and dental prosthetic Type ref. Ref. Document "LISTADO DE REFERENCIA AT001 ed. 01 dated 20/09/2016" Encls:

9 BEST-FIT Garantía de Calidad. EN GT-MEDICAL, LA RAÍZ ES LO MÁS IMPORTANTE Certificaciones de Producto Los Productos BEST-FIT que comercializamos cuentan con los siguientes Certificados que garantizan la Calidad nuestros Productos: Certificado Europeo de Calidad en sus Productos CE. Certificado Americano de Calidad en sus Productos FDA. Invertimos anualmente euros en I+D+I (Investigación + Desarrollo + Innovación) con el fin de estar en la vanguardia de las tendencias del sector, así como de las últimas tecnologías. De esta forma, logramos la Calidad de nuestros Productos tanto de clínica, como de laboratorio (materiales, recubrimientos, ajuste, estética y comodidad para el paciente), siempre probados a través de estudios. A través de la solidez que proporcionan cada uno de estos Certificados Internacionales de Calidad, buscamos ofrecer, tanto a nuestros clientes, como a todos aquellos interesados en conocernos mejor, la Garantía de nuestros Productos, Servicios y Empresa.