EN ISO 13485:2016
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Certificate No. Q5 037570 0018 Rev. 01 Holder of Certificate: RanD S.p.A. Via Statale 12 n. 62 41036 Medolla (MO) ITALY RanD S.p.A. Via Statale 12 n. 62, 41036 Medolla (MO), ITALY Certification Mark: Design and development, production, distribution and service of: equipment for extracorporeal circulation and for perfusion of warmed fluids in intracorporeal cavities, disposable devices for extracorporeal circulation and cell separation, disposable devices for perfusion of warmed fluids in intracorporeal cavities, infusion and drainage catheters for intracorporeal cavities, disposable devices for culture and preservation of animal or human cells in bio-artificial systems. Applied Standard(s): EN ISO 13485:2016 Medical devices - Quality management systems Requirements for regulatory purposes (ISO 13485:2016) DIN EN ISO 13485:2016 The Certification Body of TÜV SÜD Product Service GmbH certifies that the company mentioned above has established and is maintaining a quality management system, which meets the requirements of the listed standard(s). All applicable requirements of the testing and certification regulation of TÜV SÜD Group have to be complied with. For details and certificate validity see: www.tuvsud.com/ps-cert?q=cert:Q5 037570 0018 Rev. 01 Report No.: Valid from: Valid until: Christoph Dicks Head of Certification/Notified Body Page 1 of 1 TÜV SÜD Product Service GmbH • Certification Body • Ridlerstraße 65 • 80339 Munich