BEUDAMED
    FDA Registration Active 🇩🇴 Dominican Republic

    Attain Hybrid Guide Wire

    Reg #: 3006891611 · FEI: 3006891611 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CEA Global Dominicana d.b.a. Nissha Medical Technologies
    Registration Number
    3006891611
    FEI Number
    3006891611
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zona Franca Industrial
    City
    San Pedro de Macoris
    Country
    DO

    Regulatory Submissions

    510(k) Number
    K063210

    Owner / Operator

    Firm Name
    Nissha Medical Technologies
    Operator Number
    10023988
    Address
    400 Exchange Street
    City
    Buffalo
    State
    NY
    Postal Code
    14204
    Country
    US

    Products

    Device Name Product Code
    Wire, Guide, Catheter DQX

    Proprietary Names

    Attain Hybrid Guide Wire

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)