BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    IsoLoc

    Reg #: 3014246639 · FEI: 3014246639 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Biomerics Cartago
    Registration Number
    3014246639
    FEI Number
    3014246639
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Edificio 22-23 A to D and A4, Zona Franca Parque Industrial Zeta
    City
    Cartago
    Country
    CR

    Regulatory Submissions

    510(k) Number
    DEN130036

    Owner / Operator

    Firm Name
    Biomerics
    Operator Number
    1833117
    Address
    6030 W Harold Gatty Drive, --
    City
    Salt Lake City
    State
    UT
    Postal Code
    84116
    Country
    US
    Correspondent
    Jake Wakley

    US Agent

    Business Name
    Biomerics
    Contact Name
    Jake Wakley
    Address
    6030 W Harold Gatty Drive
    City
    Salt Lake City
    State
    UT
    ZIP
    84116
    Country
    US
    Email
    [email protected]
    Phone
    801 3552705

    Products

    Device Name Product Code
    Prostate Immobilizer Rectal Balloon PCT

    Proprietary Names

    IsoLoc

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)