BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    BioProtect Balloon Implant™ System

    Reg #: 3034364931 · FEI: 3034364931 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIOPROTECT LTD
    Registration Number
    3034364931
    FEI Number
    3034364931
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Ha Gavish 6
    City
    Netanya Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K222972

    Owner / Operator

    Firm Name
    Bioprotect Ltd
    Operator Number
    10092133
    Address
    Ha Gavish 6
    City
    Netanya
    State
    Central
    Postal Code
    4250706
    Country
    IL
    Correspondent
    George J Hattub

    US Agent

    Business Name
    Medicsense USA LLC
    Contact Name
    George Hattub
    Address
    291 Hillside Ave
    City
    Somerset
    State
    MA
    ZIP
    02726
    Country
    US
    Email
    [email protected]
    Phone
    508 4796116

    Products

    Device Name Product Code
    Hydrogel Spacer OVB

    Proprietary Names

    BioProtect Balloon Implant™ System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)