BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    MedSkin Solutions Dr. Suwelack AG

    Reg #: 3002636527 · FEI: 3002636527 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    MedSkin Solutions Dr. Suwelack AG
    Registration Number
    3002636527
    FEI Number
    3002636527
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    JOSEF-SUWELACK-STRASSE 2
    City
    BILLERBECK North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K250864

    Owner / Operator

    Firm Name
    MedSkin Solutions Dr. Suwelack AG
    Operator Number
    9083271
    Address
    JOSEF-SUWELACK-STRASSE 2, --
    City
    BILLERBECK
    State
    North Rhine-Westphalia
    Postal Code
    48727
    Country
    DE
    Correspondent
    Claudia - Doberenz

    US Agent

    Business Name
    SUWELACK MATRIX SYSTEMS, INC.
    Contact Name
    Scott Goodridge
    Address
    1540 Keller Parkway #108
    City
    Keller
    State
    TX
    ZIP
    76248
    Country
    US
    Email
    [email protected]
    Phone
    817 3374400

    Products

    Device Name Product Code
    Wound Dressing With Animal-Derived Material(S) KGN
    Filler, Bone Void, Calcium Compound MQV
    Dressing, Wound, Drug FRO

    Proprietary Names

    MatriDerm pluS+ Bi-Layer MatriDerm Puracol Plus Ag Collagen Wound Dressing Puracol-Puracol Plus

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer)