BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    SutureTOOL system

    Reg #: 3038138322 · FEI: 3038138322 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SUTURION AB
    Registration Number
    3038138322
    FEI Number
    3038138322
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Scheeleteorget 1
    City
    LUND Skane
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K250977

    Owner / Operator

    Firm Name
    Suturion
    Operator Number
    10093007
    Address
    Scheeleteorget 1
    City
    LUND
    State
    Skane
    Postal Code
    22363
    Country
    SE

    US Agent

    Business Name
    Target Health
    Contact Name
    Mittal Suthar
    Address
    110 W 40th St Fl 8
    City
    New York
    State
    NY
    ZIP
    10018
    Country
    US
    Email
    [email protected]
    Phone
    857 2336298

    Products

    Device Name Product Code
    Suture, Surgical, Absorbable, Polydioxanone NEW

    Proprietary Names

    SutureTOOL system

    Establishment Types

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