BEUDAMED
    MDR MDR QMS Issued

    CSQ002424

    Manufacturer: Bruschettini s.r.l.
    Basic UDI-DIs
    0
    Scopes
    10
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    00
    975
    Valid for 975 days
    Expiry: February 7, 2029

    Basic Information

    Number
    CSQ002424
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    July 1, 2024
    Expiry Date
    February 7, 2029
    Revision
    00
    Manufacturer
    Bruschettini s.r.l.

    Certificate Lifecycle

    July 1, 2024 February 7, 2029

    Device Characteristics

    Sterile

    Scopes

    10 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIb

    Clarastill Clarastill Sine

    Quality Procedure Scope

    Device Group Class IIb

    KERATOSEPT KERATOSEPT PRO

    Quality Procedure Scope

    Device Group Class IIb

    KERATOSTILL KERATOSTILL SINE OmniMed protect PAN-VISION KERATODROP EyeStill DualCare KORNEOL

    Quality Procedure Scope

    Device Group Class IIb

    Gel 4000

    Quality Procedure Scope

    Device Group Class IIb

    OmniMed comfort LACRI-VISION

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    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.