Acutus Medical Inc.
Medizinprodukte VO (EU) 2017/745
MDN 1203 - Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools - AcQGuide Flex and Mini Catheter Introducer Sets Mini Sheath with FlexCath Cross and Flex Sheath with FlexCath Cross Catheter Introducer Sets - AcQCross Integrated Transspetal Dilator/Needle FlexCath Cross Transseptal Solution Integrated Transseptal Dilator/Needle
MDD Confirmation Letter
Design, Development, Manufacturing, and Distribution of medical devices for accessing cardiac chambers.
Design, Development, Manufacturing, and Distribution of medical devices for accessing cardiac chambers. -AUS (a), CND, JPN, USA (a,b,c,d) REPs FEI No.: F005369
ISO 13485:2016 (MDSAP Audit Model Edition 2)
Diese Zertifizierung gehört der Muttergesellschaft 506478 Acutus Medical Inc.
Design, Development, Manufacturing, and Distribution of medical devices for accessing cardiac chambers. -AUS (a), CND, JPN, USA (a,b,c,d) REPs FEI No.: F005369