BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    ENTERPRISE 8000X (POZNAN - MFR & COMPLAINTS)

    Reg #: 3007420694 · FEI: 3007420694 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    Establishment Types
    3
    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

    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
    Bed, Ac-Powered Adjustable Hospital FNL

    Proprietary Names

    ENTERPRISE 8000X (POZNAN - MFR & COMPLAINTS) ENTERPRISE 9700X (POZNAN - MFR & COMPLAINTS) ENTERPRISE 9800X (POZNAN - MFR & COMPLAINTS) ENTERPRISE 9000 SERIES (POZNAN - COMPLAINTS) MINUET 2 (POZNAN - MFR & COMPLAINTS) BARIMAXX II (POZNAN SPEC. DEVELOPER & COMPLAINTS) CONTOURA 1080 (POZNAN - MFR & COMPLAINTS) CITADEL BED FRAME (POZNAN - MFR & COMPLAINTS) ENTERPRISE 9600X (POZNAN - MFR & COMPLAINTS) CITADEL PLUS BARIATRIC BED FRAME SYSTEM (POZNAN - MFR & COMPLAINTS) BARIMAXX ACTIVE (POZNAN SPEC. DEVELOPER & COMPLAINTS) ENTERPRISE 9000X (POZNAN - MFR & COMPLAINTS) EVENDA BED (POZNAN - MFR & COMPLAINTS) ENTERPRISE 5000X (POZNAN - MFR & COMPLAINTS)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device