BEUDAMED
    MDR MDR QMS Issued

    28620156455

    Manufacturer: SmileSonica Inc.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    00
    803
    Valid for 803 days
    Expiry: August 19, 2028

    Basic Information

    Number
    28620156455
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    September 13, 2023
    Expiry Date
    August 19, 2028
    Revision
    00
    Manufacturer
    SmileSonica Inc.

    Certificate Lifecycle

    September 13, 2023 August 19, 2028

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    Ultrasound therapy equipment

    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.