BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Epiminder America Inc

    Reg #: 3039640505 · FEI: 3039640505 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

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    Registration Details

    Registration Name
    Epiminder America Inc
    Registration Number
    3039640505
    FEI Number
    3039640505
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4545 Fuller Dr Ste 225
    City
    Irving
    State
    TX
    ZIP
    75038
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN240062

    Owner / Operator

    Firm Name
    Epiminder Limited
    Operator Number
    10093773
    Address
    525 Collins Street, West Podium, Mezzanine 2, Office 210/211
    City
    Melbourne
    State
    Victoria
    Postal Code
    3000
    Country
    AU
    Correspondent
    Tracy Cameron

    Products

    Device Name Product Code
    Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring SEM

    Proprietary Names

    Minder

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device