BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    Tula Earplug 10-Pack Size 3

    Reg #: 3003678543 · FEI: 3003678543 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    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

    PMA Number
    P190016

    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
    Tympanostomy Tube Delivery Product With Drug QJA

    Proprietary Names

    Tula Earplug 10-Pack Size 3 Tula Earplug 10-Pack Size 6 Tula Earset Spare Tula TDS 1.14 Grommet Tula Control Unit Spare Tula Kit - Bilateral Tula Earplug 10-Pack Size 5 Tymbion and Syringe Pack TYMB001 Tula Earplug Sizers Tula Earplug 10-Pack Size 2 Tula Earplug 10-Pack Size 1 Tula Earplug 10-Pack Size 4 Tula Kit - Unilateral

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)