BEUDAMED
    MDR MDR QMS Issued

    170776070

    Manufacturer: Route 92 Medical, Inc.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    0
    344
    Valid for 344 days
    Expiry: May 18, 2027

    Basic Information

    Number
    170776070
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    May 19, 2022
    Expiry Date
    May 18, 2027
    Manufacturer
    Route 92 Medical, Inc.

    Certificate Lifecycle

    May 19, 2022 May 18, 2027

    Device Characteristics

    Sterile

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class III

    MDN 1203 - Vascular Guide-Catheter, Single Use

    Quality Procedure Scope

    Device Class III

    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.