BEUDAMED
    MDR MDR QMS Supplemented

    CN23/00002940

    Manufacturer: APT Medical Inc.
    Basic UDI-DIs
    0
    Scopes
    7
    Preceding Certs
    1
    Risk Classes
    3
    Characteristics
    2
    Revision
    3
    728
    Valid for 728 days
    Expiry: June 6, 2028

    Basic Information

    Number
    CN23/00002940
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    March 20, 2024
    Expiry Date
    June 6, 2028
    Revision
    3
    Manufacturer
    APT Medical Inc.

    Certificate Lifecycle

    March 20, 2024 June 6, 2028

    Device Characteristics

    Sterile

    Scopes

    7 scopes covering 3 risk classes

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class III

    Quality Procedure Scope

    Device Group Class III

    MDN1203, MDS1005

    Quality Procedure Scope

    Device Group Class I Measuring Function Sterile

    MDN1208

    Quality Procedure Scope

    Device Class I

    Quality Procedure Scope

    Device Group Class IIa

    MDN1202 MDS1005

    Quality Procedure Scope

    Device Class IIa

    Preceding Certificates

    CN23/00002940 Supplemented
    Issued: November 22, 2023 Expires: June 6, 2028

    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.