BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    BIOPORTO DIAGNOSTICS A/S

    Reg #: 3010739981 · FEI: 3010739981 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIOPORTO DIAGNOSTICS A/S
    Registration Number
    3010739981
    FEI Number
    3010739981
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Tuborg Havnevej, 15, st
    City
    Hellerup Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K232761

    Owner / Operator

    Firm Name
    BioPorto Diagnostics A/S
    Operator Number
    10089659
    Address
    Tuborg Havnevej, 15, st
    City
    Hellerup
    State
    Hovedstaden
    Postal Code
    2900
    Country
    DK
    Correspondent
    Monika Bak

    US Agent

    Business Name
    BioPorto Diagnostics Inc.
    Contact Name
    Jennifer Zonderman
    Address
    117 Kendrick St Ste 300
    City
    Needham Heights
    State
    MA
    ZIP
    02494
    Country
    US
    Email
    [email protected]
    Phone
    617 6942918

    Products

    Device Name Product Code
    Acute Kidney Injury Test System PIG

    Proprietary Names

    ProNephro AKI™ (NGAL)

    Establishment Types

    Manufacture Medical Device