BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    BIOTEC BIOTECNOLOGIAS DE CENTROAMERICA S.A.

    Reg #: 3027242374 · FEI: 3027242374 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIOTEC BIOTECNOLOGIAS DE CENTROAMERICA S.A.
    Registration Number
    3027242374
    FEI Number
    3027242374
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Oficentro Don Hugo Local #1, 250 este del Centro Comercial Plaza Mayor
    City
    Rohrmoser San Jose
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K140855

    Owner / Operator

    Firm Name
    Biotec Biotecnologias de Centroamerica S.A.
    Operator Number
    10087853
    Address
    Oficentro Don Hugo Local #1, 250 este del Centro Comercial Plaza Mayor
    City
    Rohrmoser
    State
    San Jose
    Postal Code
    10109
    Country
    CR

    US Agent

    Business Name
    Arthrex Inc
    Contact Name
    Barry Dietz
    Address
    1370 Creekside Blvd
    City
    Naples
    State
    FL
    ZIP
    34108
    Country
    US
    Email
    [email protected]
    Phone
    800 9337001

    Products

    Device Name Product Code
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Fastener, Fixation, Biodegradable, Soft Tissue MAI

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device