BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DermoSight Dermatoscope

    Reg #: 3038715764 · FEI: 3038715764 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    DeepX Health Device Operations
    Registration Number
    3038715764
    FEI Number
    3038715764
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10 E 29th St Apt 22j
    City
    New York
    State
    NY
    ZIP
    10016
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230448

    Owner / Operator

    Firm Name
    DeepX Health LLC
    Operator Number
    10093571
    Address
    2101 L Street, NW, Suite 300
    City
    Washington
    State
    DC
    Postal Code
    20037
    Country
    US
    Correspondent
    Laurens Kraal

    Products

    Device Name Product Code
    Light Based Imaging PSN

    Proprietary Names

    DermoSight Dermatoscope DermoSight Software

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device