BEUDAMED
    FDA Registration Active 🇨🇳 China

    Breathcare Mask Cushions YF-01 Cushion, YF-02 Cushion,YP-01 Cushion,YN-02 Cushion,YN-03 Cushion

    Reg #: 3016710298 · FEI: 3016710298 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SUZHOU YUYUE MEDICAL TECHNOLOGY CO., LTD
    Registration Number
    3016710298
    FEI Number
    3016710298
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 9 Jinfeng Road, Suzhou Science & Technology Town
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K203347

    Owner / Operator

    Firm Name
    SUZHOU YUYUE MEDICAL TECHNOLOGY CO., LTD
    Operator Number
    10091669
    Address
    No. 9 Jinfeng Road, Suzhou Science & Technology Town Suzhou Jiangsu, CN 215163
    City
    Suzhou
    State
    Jiangsu
    Postal Code
    215163
    Country
    CN
    Correspondent
    Jing Qian

    US Agent

    Business Name
    Yuwell MedTech USA LLC
    Contact Name
    Dennis Snyder
    Address
    1416 Bloomington Blvd
    City
    Columbus
    State
    OH
    ZIP
    43228
    Country
    US
    Email
    [email protected]
    Phone
    440 5062691

    Products

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

    Proprietary Names

    Breathcare Mask Cushions YF-01 Cushion, YF-02 Cushion,YP-01 Cushion,YN-02 Cushion,YN-03 Cushion Breathcare Masks YP-01,YN-03,YF-02

    Establishment Types

    Manufacture Medical Device