BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module

    Reg #: 3007710608 · FEI: 3007710608 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Optomed
    Registration Number
    3007710608
    FEI Number
    3007710608
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Yrttipellontie 1
    City
    Oulu
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K180378

    Owner / Operator

    Firm Name
    Optomed Oyj
    Operator Number
    10029840
    Address
    Yrttipellontie 1
    City
    Oulu
    State
    Pohjois-Pohjanmaa
    Postal Code
    90230
    Country
    FI
    Correspondent
    Jyri Leskela

    US Agent

    Business Name
    Optomed USA Inc.
    Contact Name
    David Frasch
    Address
    5825 Glenridge Drive, Building 4, Suite 106
    City
    ATL
    State
    GA
    ZIP
    30328
    Country
    US
    Email
    [email protected]
    Phone
    404 4411900

    Products

    Device Name Product Code
    Camera, Ophthalmic, Ac-Powered HKI

    Proprietary Names

    Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module Pictor Prestige Camera with Pictor Prestige Retina Module and Pictor Prestige Anterior Module Signal Camera

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility