BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DermaSensor

    Reg #: 3017254114 · FEI: 3017254114 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DERMASENSOR INC
    Registration Number
    3017254114
    FEI Number
    3017254114
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    801 Brickell Ave Ste 1610
    City
    Miami
    State
    FL
    ZIP
    33131
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN230008

    Owner / Operator

    Firm Name
    DermaSensor Inc
    Operator Number
    10090725
    Address
    801 Brickell Ave, # 1610
    City
    Miami
    State
    FL
    Postal Code
    33131
    Country
    US

    Products

    Device Name Product Code
    Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer QZS

    Proprietary Names

    DermaSensor

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility