ANHANG I ZUR KONFORMITÄTSERKLÄRUNG ANNEX I TO DECLARATION OF CONFORMITY Handelsname Produkt: Trade name product: Cube Reader Versionen: Versions: Flat; Cavity Basic UDI-DI: DIE FOLGENDEN VARIANTEN DES O.G. PRODUKTES SIND IN DER KONFORMITÄTSERKLÄRUNG EINGESCHLOSSEN. THE FOLLOWING VARIANTS OF THE ABOVE-MENTIONED PRODUCT ARE INCLUDED IN THE DECLARATION OF CONFORMITY. Unterschrift: Signature: Name und Funktion bei opTricon GmbH / Name and function at opTricon GmbH

KONFORMITÄTSERKLÄRUNG / DECLARATION OF CONFORMITY Name und Adresse des Herstellers: Name and address of the Manufacturer: opTricon GmbH Schwarzschildstr.1 12489 Berlin Germany SRN des Herstellers (EUDAMED): SRN of the Manufacturer (EUDAMED): DER HERSTELLER ERKLÄRT HIERMIT, DASS ER DIE ALLEINIGE VERANTWORTUNG FÜR DIE AUSSTELLUNG DER EUKONFORMITÄTSERKLÄRUNG TRÄGT. THE MANUFACTURER HEREBY DECLARES THAT HE IS SOLELY RESPONSIBLE FOR ISSUING THE EU DECLARATION OF CONFORMITY. DER HERSTELLER ERKLÄRT WEITERHIN, DASS DAS IN-VITRO-DIAGNOSTIKUM: THE MANUFACTURER FURTHER STATES THAT THE IN VITRO DIAGNOSTIC...

MIT DER FOLGENDEN ZWECKBESTIMMUNG: WITH THE FOLLOWING PURPOSE: Softwarezubehor (PC); Nur in Kombination mit Cube Reader zu verwenden; Ermoglicht den Export der Ergebnisdaten vom Reader zum PC und die Steuerung des Readers durch die Software uber den PC Software accessory (PC); Only to be used in combination with Cube Reader; Allows result data export from reader to PC and control of the reader through the software via the PC WIE FOLGT KLASSIFIZIERT WERDEN NACH VERORDNUNG (EU) 2017/746 UBER IN-VITRO-DIAGNOSTIKA (IVDR): ARE CLASSIFIED AS FOLLOWS ACCORDING TO THE IN VITRO DIAGNOSTIC MEDICAL DEVICES...

DÉCLARATION DE CONFORMITÉ / DECLARATION OF CONFORMITY Nom et adresse du fabricant : Name and address of the Manufacturer: opTricon GmbH Schwarzschildstr.1 12489 Berlin Germany SRN du fabricant (EUDAMED) : SRN of the Manufacturer (EUDAMED): LE FABRICANT DECLARE PAR LA PRESENTE QU'IL EST SEUL RESPONSABLE DE LA DELIVRANCE DE LA DECLARATION UE DE CONFORMITE. THE MANUFACTURER HEREBY DECLARES THAT HE IS SOLELY RESPONSIBLE FOR ISSUING THE EU DECLARATION OF CONFORMITY. LE FABRICANT PRECISE EN OUTRE QUE LE DISPOSITIF MEDICAL DE DIAGNOSTIC IN VITRO : THE MANUFACTURER FURTHER STATES THAT THE IN VITRO DIAGNOSTIC...

WITH THE FOLLOWING PURPOSE: SONT CLASSES COMME SUIT SELON LE REGLEMENT (UE) 2017/746 RELATIF AUX DISPOSITIFS MEDICAUX DE DIAGNOSTIC IN VITRO (IVDR) : ARE CLASSIFIED AS FOLLOWS ACCORDING TO THE IN VITRO DIAGNOSTIC MEDICAL DEVICES REGULATION (EU) 2017/746 (IVDR): H Classe A, Annexe VIII, Regie 5 b / Device of Class A, Annex VIII, Rule 5 b □ Classe B, Annexe VIII, Regie ... / Device of Class B, Annex VIII, Rule ... □ Classe C, Annexe VIII, Regie ... / Device of Class C, Annex VIII, Rule ... □ Classe D, Annexe VIII, Regle ... / Device of Class D, Annex VIII, Rule ... ET SE CONFORMER A TOUTES LES...

DICHIARAZIONE DI CONFORMITÀ / DECLARATION OF CONFORMITY Nome e indirizzo del produttore: Name and address of the Manufacturer: opTricon GmbH Schwarzschildstr.1 12489 Berlin Germany SRN del produttore (EUDAMED): SRN of the Manufacturer (EUDAMED): IL PRODUTTORE DICHIARA DI ESSERE L'UNICO RESPONSABILE DEL RILASCIO DELLA DICHIARAZIONE DI CONFORMITÀ UE. THE MANUFACTURER HEREBY DECLARES THAT HE IS SOLELY RESPONSIBLE FOR ISSUING THE EU DECLARATION OF CONFORMITY. IL FABBRICANTE DICHIARA INOLTRE CHE IL DISPOSITIVO MEDICO DIAGNOSTICO IN VITRO: THE MANUFACTURER FURTHER STATES THAT THE IN VITRO DIAGNOSTIC...

WITH THE FOLLOWING PURPOSE: Accessori software (PC); Da utilizzare solo in combinazione con Cube Reader; Consente i'esportazione dei dati dei risultati dal lettore al PC e il controllo del lettore tramite il software tramite PCSoftware accessory (PC); Only to be used in combination with Cube Reader; Allows result data export from reader to PC and control of the reader through the software via the PC SONO CLASSIFICATI COME SEGUE SECONDO IL REGOLAMENTO (UE) 2017/746 SUI DISPOSITIVI MEDICO-DIAGNOSTICI IN VITRO (IVDR): ARE CLASSIFIED AS FOLLOWS ACCORDING TO THE IN VITRO DIAGNOSTIC MEDICAL DEVICES...