BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    WiZARD 310 Nasal Mask

    Reg #: 8043439 · FEI: 3004411059 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Wellell Inc.
    Registration Number
    8043439
    FEI Number
    3004411059
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 9, MIN SHENG ST., TU-CHENG
    City
    NEW TAIPEI CITY
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K182394

    Owner / Operator

    Firm Name
    Wellell Inc.
    Operator Number
    9001426
    Address
    No. 9, MIN SHENG ST., TU-CHENG,
    City
    NEW TAIPEI CITY
    State
    TW-TPE
    Postal Code
    236044
    Country
    TW
    Correspondent
    Chieh - Yang

    US Agent

    Business Name
    WELLELL AMERICA CORP.
    Contact Name
    Elsa Chu
    Address
    927 Mariner Street, Brea, CA 92821, USA
    City
    Brea
    State
    CA
    ZIP
    92821
    Country
    US
    Email
    [email protected]
    Phone
    714 6713818

    Products

    Device Name Product Code
    Ventilator, Non-Continuous (Respirator) BZD

    Proprietary Names

    WiZARD 310 Nasal Mask WiZARD 320 Full Face Mask WiZARD 310 Nasal Mask(M) WiZARD 310 Nasal Mask(S) WiZARD 320 Full Face Mask(S) WiZARD 320 Full Face Mask(M) WiZARD 310 Nasal Mask(S/M/L) WiZARD 320 Full Face Mask(L) WiZARD 320 Full Face Mask(S/M/L)

    Establishment Types

    Manufacture Medical Device