Customers and certificates

Acutus Medical Inc.

Business Sector:
Active non-implantable imaging devices utilising non-ionizing radiation, Non-active device for anaesthesia, emergency and intensive care, Monitoring devices of vital physiological parameters
Reference No.:
506478
Certified according to :

Medical Devices VO (EU) 2017/745

Download certificate : 11.06.2025 englisch

Scope:

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

Scope:

MDD Confirmation Letter

Certified according to :
Scope:

Design, Development, Manufacturing, and Distribution of medical devices for accessing cardiac chambers.

Certified according to :
Scope:

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

Certified according to :
Scope:

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