BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    Exacta Percutaneous Sheath Introducer

    Reg #: 8020616 · FEI: 3002806476 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Merit Medical Singapore Pte. Ltd.
    Registration Number
    8020616
    FEI Number
    3002806476
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    198 YISHUN AVE. 7
    City
    SINGAPORE Central Singapore
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K941428

    Owner / Operator

    Firm Name
    Merit Medical Systems, Inc.
    Operator Number
    1721504
    Address
    1600 West Merit Parkway, --
    City
    South Jordan
    State
    UT
    Postal Code
    84095
    Country
    US

    US Agent

    Business Name
    Merit Medical Systems, Inc.
    Contact Name
    John Knorpp
    Address
    1600 West Merit Parkway
    City
    South Jordan
    State
    UT
    ZIP
    84095
    Country
    US
    Email
    [email protected]
    Phone
    801 2084795

    Products

    Device Name Product Code
    Introducer, Catheter DYB

    Proprietary Names

    Exacta Percutaneous Sheath Introducer

    Establishment Types

    Manufacture Medical Device