BEUDAMED
    FDA Registration Active 🇫🇷 France

    PHAKOS

    Reg #: 3006142778 · FEI: 3006142778 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    PHAKOS
    Registration Number
    3006142778
    FEI Number
    3006142778
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    62 rue kleber
    City
    Montreuil Seine-Saint-Denis
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K173944

    Owner / Operator

    Firm Name
    PHAKOS
    Operator Number
    10024840
    Address
    62 rue kleber
    City
    Montreuil
    State
    Seine-Saint-Denis
    Postal Code
    93100
    Country
    FR

    US Agent

    Business Name
    THE ORTHOMEDIX GROUP, INC.
    Contact Name
    J.D. Webb
    Address
    4313 W 3800 S
    City
    West Haven
    State
    UT
    ZIP
    84401
    Country
    US
    Email
    [email protected]
    Phone
    512 5905810

    Products

    Device Name Product Code
    Clip, Iris Retractor HOC
    Lens, Contact, Polymethylmethacrylate, Diagnostic HJK
    Unit, Cryophthalmic, Ac-Powered HRN
    Cannula, Ophthalmic HMX

    Proprietary Names

    Disposable Vitrectomy Lenses PHAKOS Disposable Retinal Cryo Probe Frigitronics Cryoprobe Adapter Keeler ACU/CTU Cryoprobe Adapter Dorc Classic Cryoprobe Adapter Cryomaster I Cryoprobe Adapter Erbe / Optikon Cryoprobe Adapter Cryomaster II Cryoprobe Adapter Dorc Cryostar Cryoprobe Adapter

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility