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.
- Certificate no.
- 718568
- Issued
- 2023-11-29
- Valid
- 5 years or until expiry of the EU Declaration of Conformity or NB Certificate if applicable, whichever comes first
- Devices
- Risk class A; EU Declaration of Conformity by Arena BioScien signed 28/10/2023; no notified body certificate (N.A.)
