BEUDAMED
    MDR MDR QMS Issued

    1000165613

    Manufacturer: Acutus Medical, Inc.
    Basic UDI-DIs
    0
    Scopes
    9
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    0
    Revision
    0

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    475
    Valid for 475 days
    Expiry: November 14, 2027

    Basic Information

    Number
    1000165613
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    February 22, 2024
    Expiry Date
    November 14, 2027
    Manufacturer
    Acutus Medical, Inc.

    Certificate Lifecycle

    February 22, 2024 November 14, 2027

    Scopes

    9 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class III

    Quality Procedure Scope

    Device Class III

    Quality Procedure Scope

    Device Class III

    Quality Procedure Scope

    Device Group Class IIb

    MDA 0202 - Active non-implantable imaging devices utilising non-ionizing radiation

    Quality Procedure Scope

    Device Group Class III

    MDA 0202 - Active non-implantable imaging devices utilising non-ionizing radiation

    Quality Procedure Scope

    Device Group Class III

    MDN 1203 - Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools

    Quality Procedure Scope

    Device Class III

    Quality Procedure Scope

    Device Class IIb

    Basic UDI-DIs

    This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.