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Declaration for IH-IVD Bilingual Master CENTOGENE Spain S.L.U.

CENTOGENE SPAIN S.L.U. declares that the in-house in vitro diagnostic devices listed in the attached public document are manufactured and used exclusively within CENTOGENE SPAIN S.L.U. and comply with the applicable general safety and performance requirements (GSPR) set out in Annex I to Regulation (EU) 2017/746 on in vitro diagnostic medical devices.