BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    FG100-R REGULAR FOOT GARMENT (POZNAN - MFR & COMPLAINTS)

    Reg #: 3007420694 · FEI: 3007420694 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ArjoHuntleigh Polska Sp. zo.o.
    Registration Number
    3007420694
    FEI Number
    3007420694
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Ul. Ks. Wawrzyniaka 2, Komorniki
    City
    Poznan Wielkopolskie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K965153

    Owner / Operator

    Firm Name
    ARJOHUNTLEIGH AB
    Operator Number
    8010077
    Address
    Hans Michelsensgatan 10
    City
    Malmo
    State
    Skane
    Postal Code
    211 20
    Country
    SE

    US Agent

    Business Name
    Arjo Inc
    Contact Name
    Darren Demerritt
    Address
    2349 W Lake St, #250
    City
    Addison
    State
    IL
    ZIP
    60101
    Country
    US
    Email
    [email protected]
    Phone
    425 3089587

    Products

    Device Name Product Code
    Sleeve, Limb, Compressible JOW

    Proprietary Names

    FG100-R REGULAR FOOT GARMENT (POZNAN - MFR & COMPLAINTS) FG200-R LARGE FOOT GARMENT (POZNAN - MFR & COMPLAINTS)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device