Certificates

Quality you can verify.

All our products are of high quality, meet modern-day standards and are certified with the CE Mark as well as ISO 13485:2016.

CE Mark (IVDR)

Certificate of Verification from MDSS GmbH confirming that an Authorized Representative's Mandate according to EU Regulation 2017/746 (IVDR) is in place for Arena BioScien. MDSS verified that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer. Valid only for the devices listed in the certificate: BioScien blood culture media, bacteriology powder media and transport media. The certificate states that it is not a proof for compliance to CE marking.

View certificate (PDF, 511 KB)

GMP

Good Manufacturing Practices (GMP) certificate issued by CERTIFICA to ARENA BioScien - Free Zone, Ismailia Free Zone, Ismailia, Egypt. Scope: design, development and manufacture of in vitro diagnostic reagents, instruments and laboratory devices.

View certificate (PDF, 344 KB)

ISO 13485:2016

Medical devices — quality management systems. Certificate issued by ABC Certification to ARENA BIOSCIEN - FREE ZONE, Ismailia Free Zone, Ismailia, Egypt. Scope: design, development and manufacture of in vitro diagnostic reagents, instruments and laboratory devices.

View certificate (PDF, 1.1 MB)

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Quality you can verify.

CE Mark (IVDR)

GMP

ISO 13485:2016

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