BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Elite SPK Kit

    Reg #: 3011410128 · FEI: 3011410128 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NCS LAB SRL
    Registration Number
    3011410128
    FEI Number
    3011410128
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Pola Esterna 4/12
    City
    Carpi Modena
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K160500

    Owner / Operator

    Firm Name
    NCS Lab Srl
    Operator Number
    10050099
    Address
    Via Pola Esterna 4/12
    City
    Carpi
    State
    Modena
    Postal Code
    41012
    Country
    IT
    Correspondent
    Matteo Mantovani

    US Agent

    Business Name
    MEDAGENT Inc.
    Contact Name
    Franz Menean
    Address
    264 Lafayette Rd Ste 7
    City
    Portsmouth
    State
    NH
    ZIP
    03801
    Country
    US
    Email
    [email protected]
    Phone
    603 5702039

    Products

    Device Name Product Code
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Proprietary Names

    Elite SPK Kit Compasso Elite SPK

    Establishment Types

    Manufacture Medical Device