BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    UniFuse Infusion System

    Reg #: 3003678543 · FEI: 3003678543 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Biomerics Alajuela
    Registration Number
    3003678543
    FEI Number
    3003678543
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SARET INDUSTRIAL PARK, BLDG. D-3, C-7, C-2/C-3, C-4, E-2
    City
    ALAJUELA
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K163356

    Owner / Operator

    Firm Name
    Biomerics
    Operator Number
    10042380
    Address
    6030 W Harold Gatty Drive
    City
    Salt Lake City
    State
    UT
    Postal Code
    84116
    Country
    US
    Correspondent
    Jacob J 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
    Mechanical Thrombolysis Catheter QEY

    Proprietary Names

    UniFuse Infusion System Pulse Spray Infusion System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)