BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    neoClose Hasson 8/10 Port Closure Kit (US)

    Reg #: 3010155673 · FEI: 3010155673 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TECHNOCHEMIA
    Registration Number
    3010155673
    FEI Number
    3010155673
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Fabryczna 3
    City
    Grojec Mazowieckie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K142903

    Owner / Operator

    Firm Name
    Technochemia
    Operator Number
    10042233
    Address
    Fabryczna 3
    City
    Grojec
    State
    Mazowieckie
    Postal Code
    05-600
    Country
    PL
    Correspondent
    Adam Sztaba

    US Agent

    Business Name
    SteriPack USA (Limited) LLC
    Contact Name
    Marinela Cebic
    Address
    4255 S Pipkin Rd
    City
    Lakeland
    State
    FL
    ZIP
    33811
    Country
    US
    Email
    [email protected]
    Phone
    863 6482333

    Products

    Device Name Product Code
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    neoClose Hasson 8/10 Port Closure Kit (US) neoClose AnchorGuide 8/15 Port Closure Kit (1 Port) (US) neoClose AnchorGuide 5/15 Port Closure Kit (2 Ports) (US) neoClose AnchorGuide 5/12 Port Closure Kit (1 Port) (US) neoClose Hasson 10/12 Port Closure Kit (US) neoClose AnchorGuide Regular Port Closure Kit (US) neoClose AnchorGuide Regular Port Closure Kit X2 (US) neoClose AnchorGuide XL Port Closure Kit (US) neoClose 4 AutoAnchor Pack (US)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)