BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    EndoDrill Model X with Article No. 3000-01 Endodrill Drive System and Article No. 1005-40 Endodrill GI 17G

    Reg #: 3027641465 · FEI: 3027641465 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BIBB INSTRUMENTS AB
    Registration Number
    3027641465
    FEI Number
    3027641465
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Medicon Village, SE-223 81
    City
    Lund Skane
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K212423

    Owner / Operator

    Firm Name
    Bibb Instruments AB
    Operator Number
    10088463
    Address
    Medicon Village, SE-223 81
    City
    Lund
    State
    Skane
    Postal Code
    223 81
    Country
    SE
    Correspondent
    Fredrik Lindblad

    US Agent

    Business Name
    OMEDtech
    Contact Name
    David Makanani
    Address
    8501 Lullwater Dr., #1208
    City
    Dallas
    State
    TX
    ZIP
    75238
    Country
    US
    Email
    [email protected]
    Phone
    405 8260713

    Products

    Device Name Product Code
    Biopsy Needle FCG

    Proprietary Names

    EndoDrill Model X with Article No. 3000-01 Endodrill Drive System and Article No. 1005-40 Endodrill GI 17G

    Establishment Types

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