BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Eyer 2 Basic

    DI: 07908616100097 · Model: Eyer 2 Basic · PHELCOM TECHNOLOGIES SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Eyer 2 Basic
    Primary DI
    07908616100097
    Version / Model
    Eyer 2 Basic
    Company Name
    PHELCOM TECHNOLOGIES SA
    Labeler DUNS
    945005233
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-09-23
    Public Version
    1
    Public Version Date
    2024-10-01
    Public Version Status
    New
    Public Device Record Key
    e7e805f2-5669-43cf-a9b2-84ed6095a1b6

    Device Description

    Eyer 2 Basic

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PJZ Camera, Ophthalmic, General-Use

    GMDN Terms

    Code Name
    10551 Ophthalmic fundus camera

    Identifiers

    Type ID
    Primary 07908616100097