BEUDAMED
    MDR MDR QA Issued

    DZ 2372869-1

    Manufacturer: FOMED INDUSTRIES INC.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    1
    Revision
    0
    769
    Valid for 769 days
    Expiry: July 16, 2028

    Basic Information

    Number
    DZ 2372869-1
    Type
    MDR QA
    Legislation
    MDR
    Issue Date
    July 17, 2023
    Expiry Date
    July 16, 2028
    Manufacturer
    FOMED INDUSTRIES INC.

    Certificate Lifecycle

    July 17, 2023 July 16, 2028

    Device Characteristics

    Sterile

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    M020103-LAPAROTOMY COTTON GAUZES M020102-COTTON GAUZES, FOLDED

    Quality Procedure Scope

    Device Group Class I Sterile

    M020102-COTTON GAUZES, FOLDED M020201-NON-WOVEN FOLDED GAUZES M040201-ABSORBENT DRESSINGS WITH CELLULOSE PAD AND NON-WOVEN WRAPS

    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.