BEUDAMED
    IVDR IVDR QMS Issued

    HX 1774385-1

    Manufacturer: Hamilton Bonaduz AG
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    Rev. 0
    1195
    Valid for 1195 days
    Expiry: September 15, 2029

    Basic Information

    Number
    HX 1774385-1
    Type
    IVDR QMS
    Legislation
    IVDR
    Issue Date
    September 16, 2024
    Expiry Date
    September 15, 2029
    Revision
    Rev. 0
    Manufacturer
    Hamilton Bonaduz AG

    Certificate Lifecycle

    September 16, 2024 September 15, 2029

    Device Characteristics

    Sterile

    Conditions

    English

    The scope of certification is limited to the aspects relating to establishing, securing and maintaining sterile conditions.

    Scopes

    Quality Procedure Scope

    Device Group Class A

    IVR 0801: Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746 W0580 - IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES

    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.