BEUDAMED
    MDR MDR QMS Supplemented

    1000169818

    Manufacturer: Perflow Medical Ltd.
    Basic UDI-DIs
    0
    Scopes
    6
    Preceding Certs
    1
    Risk Classes
    2
    Characteristics
    0
    Revision
    03
    485
    Valid for 485 days
    Expiry: October 6, 2027

    Basic Information

    Number
    1000169818
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    May 15, 2024
    Expiry Date
    October 6, 2027
    Revision
    03
    Manufacturer
    Perflow Medical Ltd.

    Certificate Lifecycle

    May 15, 2024 October 6, 2027

    Device Characteristics

    Sterile

    Scopes

    6 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Class III

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Group Class III

    MDN 1203 - Neurovascular remodeling device

    Quality Procedure Scope

    Device Class III

    Quality Procedure Scope

    Device Group Class III

    MDN 1203 - Neurovascular thrombectomy device

    Quality Procedure Scope

    Device Group Class IIa

    MDN 1203 - Neurovascular remodeling device

    Preceding Certificates

    170783436 Supplemented
    Issued: March 3, 2023 Expires: October 6, 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.