BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Dreem 3 System

    Reg #: 3012428212 · FEI: 3012428212 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    COMPAL ELECTRONICS, INC
    Registration Number
    3012428212
    FEI Number
    3012428212
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1,2,3,4,5F No.8-1 & 1,2F No.8, Nandong Rd., Pingzhen Dist.
    City
    Taoyuan City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K223539

    Owner / Operator

    Firm Name
    COMPAL ELECTRONICS, INC
    Operator Number
    10059337
    Address
    No. 581, Ruiguang Rd., Neihu District, Taipei City
    City
    Taipei City
    State
    TW-TPE
    Postal Code
    11492
    Country
    TW
    Correspondent
    Casper Chen

    US Agent

    Business Name
    ProMedic, LLC
    Contact Name
    Matt Dryden
    Address
    131 Bay Point Dr. NE
    City
    Saint Petersburg
    State
    FL
    ZIP
    33704
    Country
    US
    Email
    [email protected]
    Phone
    239 3076063

    Products

    Device Name Product Code
    Automatic Event Detection Software For Polysomnograph With Electroencephalograph OLZ
    Standard Polysomnograph With Electroencephalograph OLV

    Proprietary Names

    Dreem 3 System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)