BEUDAMED
    MDR MDR QMS Supplemented

    003-00-10-MDR

    Manufacturer: STERYLAB S.R.L.
    Basic UDI-DIs
    0
    Scopes
    16
    Preceding Certs
    1
    Risk Classes
    3
    Characteristics
    2
    Revision
    10
    456
    Valid for 456 days
    Expiry: September 7, 2027

    Basic Information

    Number
    003-00-10-MDR
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    April 4, 2024
    Expiry Date
    September 7, 2027
    Revision
    10
    Manufacturer
    STERYLAB S.R.L.

    Certificate Lifecycle

    April 4, 2024 September 7, 2027

    Device Characteristics

    Sterile

    Scopes

    16 scopes covering 3 risk classes

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Group Class IIa

    Non-active non-implantable devices for administration, channelling and removal of substances

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Group Class IIa

    Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis

    Quality Procedure Scope

    Device Group Class IIa

    Non-active non-implantable instruments

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Group Class IIa

    Non-active non-implantable devices for removal of substances

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class I Measuring Function Sterile

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Group Class IIb

    Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis

    Quality Procedure Scope

    Device Group Class IIa

    Non-implantable instruments for soft tissue biopsy

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Preceding Certificates

    003-00-09-MDR Supplemented
    Issued: September 28, 2023 Expires: September 7, 2027

    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.