BEUDAMED
    MDR MDR QMS Issued

    28620177096

    Manufacturer: Amalgam Rx, Inc
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    00
    846
    Valid for 846 days
    Expiry: October 2, 2028

    Basic Information

    Number
    28620177096
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    June 4, 2024
    Expiry Date
    October 2, 2028
    Revision
    00
    Manufacturer
    Amalgam Rx, Inc

    Certificate Lifecycle

    June 4, 2024 October 2, 2028

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    Software

    Quality Procedure Scope

    Device Class IIa

    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.