BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    WiZARD 210 Nasal Mask (M) (SM01009)

    Reg #: 8043439 · FEI: 3004411059 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    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
    K103174

    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 210 Nasal Mask (M) (SM01009) WiZARD 210 Nasal Mask (S) (SM01010) WiZARD 210 Nasal Mask (XS) (SM01011) WiZARD 220 Full Face Mask (L) (SM02010) WiZARD 220 Full Face Mask (S) (SM02012) WiZARD 220 Full Face Mask (M) (SM02011) WiZARD 210 Nasal Mask (L) (SM01008) SM00006, WiZARD 220 Full Face Mask Cushion, S SM00004, WiZARD 220 Full Face Mask Cushion, L SM00030, WiZARD 210 Nasal Mask Cushin, XS SM00005, WiZARD 220 Full Face Mask Cushion, M SM00001, WiZARD 210 Nasal Mask Cushin, L SM00016, Small Silicon Tubing SM00003, WiZARD 210 Nasal Mask Cushin, S SM00002, WiZARD 210 Nasal Mask Cushin, M

    Establishment Types

    Manufacture Medical Device