BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇳 China

    Redermax Antibacterial Wound Matrix

    K Number: K251582 · Decision Feb 2, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    2
    Review Days
    255

    Basic Information

    Device Name
    Redermax Antibacterial Wound Matrix
    K Number
    K251582
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beijing Kreate Medical Co., Ltd.
    Date Received
    May 23, 2025
    Decision Date
    February 2, 2026
    Product Code
    FRO
    Advisory Committee
    Unknown
    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
    FRO Dressing, Wound, Drug

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    Other Clearances by Beijing Kreate Medical Co., Ltd.

    K Number Device Name
    K260020 Redermo Wound Matrix