BEUDAMED
    FDA Registration Active 🇩🇴 Dominican Republic

    T7 Hood with Anti-Reflective Face Shield

    Reg #: 3007309299 · FEI: 3007309299 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AccuMed Corp.
    Registration Number
    3007309299
    FEI Number
    3007309299
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zona Franca de Nigua, Nigua Buildings
    City
    Nigua San Cristobal
    Country
    DO

    Regulatory Submissions

    510(k) Number
    K200493

    Owner / Operator

    Firm Name
    AccuMed Corp
    Operator Number
    10040676
    Address
    1001 Military Cutoff RD, Suite 300
    City
    Wilmington
    State
    NC
    Postal Code
    28405
    Country
    US
    Correspondent
    Zoila Jimenez

    Products

    Device Name Product Code
    Hood, Surgical FXY

    Proprietary Names

    T7 Hood with Anti-Reflective Face Shield T7Plus Hood with Anti-Reflective Face Shield T7 Hood with Peel Away Face Shield T7Plus Hood with Peel Away Face Shield

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)