BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Qualine WC

    Reg #: 2437956 · FEI: 3002357954 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ASSEMBLY REQUIRED DI
    Registration Number
    2437956
    FEI Number
    3002357954
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5507 Nesconset Hwt. #10, Ste 336
    City
    Mount Sinai
    State
    NY
    ZIP
    11766
    Country
    US

    Regulatory Submissions

    510(k) Number
    K973418

    Owner / Operator

    Firm Name
    ASSEMBLY REQUIRED DIST.
    Operator Number
    9031473
    Address
    5507 Nesconset Hwy #10, --336
    City
    Mount Sinai
    State
    NY
    Postal Code
    11766
    Country
    US
    Correspondent
    DOREEN - MURPHY

    Products

    Device Name Product Code
    Wheelchair, Mechanical IOR

    Proprietary Names

    Qualine WC

    Establishment Types

    Repack or Relabel Medical Device