BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OSYPKA MEDTEC INC.

    Reg #: 3010376846 · FEI: 3010376846 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    OSYPKA MEDTEC INC.
    Registration Number
    3010376846
    FEI Number
    3010376846
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1804 Skyway Dr Unit E
    City
    Longmont
    State
    CO
    ZIP
    80504
    Country
    US

    Regulatory Submissions

    510(k) Number
    K102199

    Owner / Operator

    Firm Name
    Osypka Medtec Inc.
    Operator Number
    10044669
    Address
    1804 Skyway Dr. Unit E
    City
    Longmont
    State
    CO
    Postal Code
    80504
    Country
    US
    Correspondent
    Dana D Tompkins

    Products

    Device Name Product Code
    Hearing Aid, Bone Conduction LXB

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device