BEUDAMED
    FDA Registration Active 🇳🇴 Norway

    OFC100L, Oivi Fundus Camera

    Reg #: 3029906968 · FEI: 3029906968 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    OIVI AS
    Registration Number
    3029906968
    FEI Number
    3029906968
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Gaustadalleen 21
    City
    Oslo
    Country
    NO

    Owner / Operator

    Firm Name
    Oivi AS
    Operator Number
    10088795
    Address
    Karenslyst Alle 16D
    City
    Oslo
    State
    NO-03
    Postal Code
    0278
    Country
    NO

    US Agent

    Business Name
    QA/RA Consulting Group, Inc.
    Contact Name
    Scott Bednar
    Address
    3335 Tuscarawas Road
    City
    Beaver
    State
    PA
    ZIP
    15009
    Country
    US
    Email
    [email protected]
    Phone
    412 4188066

    Products

    Device Name Product Code
    Camera, Ophthalmic, General-Use PJZ

    Proprietary Names

    OFC100L, Oivi Fundus Camera

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device