BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    ECHO

    Reg #: 3015658550 · FEI: 3015658550 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NORLASE APS
    Registration Number
    3015658550
    FEI Number
    3015658550
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Brydehusvej 13
    City
    Ballerup Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K222157

    Owner / Operator

    Firm Name
    Norlase ApS
    Operator Number
    10061124
    Address
    Brydehusvej 13
    City
    Ballerup
    State
    Hovedstaden
    Postal Code
    2750
    Country
    DK
    Correspondent
    Jan F Bitz

    US Agent

    Business Name
    Norlase Inc
    Contact Name
    Greg Fava
    Address
    895 Hurlingame Ave
    City
    Redwood City
    State
    CA
    ZIP
    94063
    Country
    US
    Email
    [email protected]
    Phone
    650 4890083

    Products

    Device Name Product Code
    Laser, Ophthalmic HQF

    Proprietary Names

    ECHO

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198