DECLARATION OF CONFORMITY ERG-Jet
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DECLARATION OF CONFORMITY We, Fabrinal SA Rue de la Tuilerie 42 CH-2300 La Chaux-de-Fonds Switzerland SRN : CH-MF-000015863 declare under our sole responsibility that the class IIa medical device, Product Name Basic UDI-DI The ERG-Jet is used to support diagnostic systems for anomalies of the eye by transmitting the retinal electrical signal. It is indicated in various clinical situations such as the assessment of retinal functions and neurological disorders. from Lot AFV 2020-05 and until July 4, 2023, is in conformity with annexes V, section 4 and VII of the EC Directive 93/42 and with current applicable harmonized standards. Notified Body CE 0123 TüvSüd Product Service GmbH Ridlerstrasse 65 80339 Munich, Germany Medidee Services (Deutschland) GmbH Hohnenweg 9 78098 Triberg Baden-Württemberg, Germany SRN : DE-AR-000005578 Place, Date : Name, Function and Signature Cloé Houriet, Director : ________________