BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    Actim PROM Controls

    Reg #: 3013143953 · FEI: 3013143953 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Actim Oy Manufacturing Site
    Registration Number
    3013143953
    FEI Number
    3013143953
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Noljakantie 13,, ,
    City
    Joensuu Pohjois-Karjala
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K123986

    Owner / Operator

    Firm Name
    Actim Oy
    Operator Number
    10048029
    Address
    Klovinpellontie 3
    City
    Espoo
    State
    Uusimaa
    Postal Code
    FI-02180
    Country
    FI
    Correspondent
    Tiina Vilkkinen

    US Agent

    Business Name
    Icon Clinical Research
    Contact Name
    Jamie Harris
    Address
    731 Arbor Way Ste 100
    City
    Blue Bell
    State
    PA
    ZIP
    19422
    Country
    US
    Email
    [email protected]
    Phone
    661 6459048

    Products

    Device Name Product Code
    Immunoassay, Insulin-Like Growth Factor Binding Protein-1 OAM

    Proprietary Names

    Actim PROM Controls Actim PROM

    Establishment Types

    Manufacture Medical Device