BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇸🇪 Sweden

    Amferia Wound Dressing

    K Number: DEN250006 · Decision Feb 6, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    340

    Basic Information

    Device Name
    Amferia Wound Dressing
    K Number
    DEN250006
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    878.4013
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Amferia AB
    Date Received
    March 3, 2025
    Decision Date
    February 6, 2026
    Product Code
    SHA
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SHA Solid Wound Dressing With Permanently Bound Antimicrobial Agent