BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    SM00017, L Nasal Pillows Cushion

    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
    K121642

    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

    SM00017, L Nasal Pillows Cushion SM00022, Elbow Connector with Short Tube SM00020, XS Nasal Pillows Cushion SM00019, S Nasal Pillows Cushion SM03001, Mr. WiZARD 230 Nasal Pillows Mask with Headgear SM00018, M Nasal Pillows Cushion SM00021, Mask Frame SM00023, Headgear Set, Lavender SM00024, Headgear Set, Light Blue

    Establishment Types

    Manufacture Medical Device