BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CytoPen NG

    Reg #: 3007645866 · FEI: 3007645866 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EMAGE MEDICAL, LLC
    Registration Number
    3007645866
    FEI Number
    3007645866
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7515 Robin Crest Rd
    City
    Charlotte
    State
    NC
    ZIP
    28226
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230420

    Owner / Operator

    Firm Name
    Emage Medical, LLC
    Operator Number
    10082979
    Address
    7515 Robin Crest Rd
    City
    Charlotte
    State
    NC
    Postal Code
    28226
    Country
    US
    Correspondent
    Lonnie Roy Wallace

    Products

    Device Name Product Code
    Powered Microneedle Device QAI

    Proprietary Names

    CytoPen NG

    Establishment Types

    Repack or Relabel Medical Device