BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    DiviTumTKa

    Reg #: 3008629194 · FEI: 3008629194 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BIOVICA INTERNATIONAL AB
    Registration Number
    3008629194
    FEI Number
    3008629194
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Uppsala Science Park, Dag Hammarskjolds vag 54 B
    City
    Uppsala
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K202852

    Owner / Operator

    Firm Name
    BIOVICA International AB
    Operator Number
    10085854
    Address
    Uppsala Science Park, Dag Hammarskjolds vag 54 B
    City
    Uppsala
    State
    SE-C
    Postal Code
    75237
    Country
    SE

    US Agent

    Business Name
    Biovica Inc.
    Contact Name
    Hector Tamburini
    Address
    6195 Cornerstone Court, Suite 101
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US
    Email
    [email protected]
    Phone
    858 2306164

    Products

    Device Name Product Code
    Thymidine Kinase Activity QTE

    Proprietary Names

    DiviTumTKa DiviTum

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device