BEUDAMED
    FDA Registration Active 🇨🇳 China

    Polyisoprene Surgical gloves

    Reg #: 3008062466 · FEI: 3008062466 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Suzhou Colour-way New Material Co., Ltd.
    Registration Number
    3008062466
    FEI Number
    3008062466
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 20, Anmin Road, Huangdai Town, Xiangcheng District
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K240790

    Owner / Operator

    Firm Name
    Suzhou Colour-way New Material Co., Ltd.
    Operator Number
    10030755
    Address
    No. 20, Anmin Road, Huangdai Town, Xiangcheng District
    City
    Suzhou
    State
    Jiangsu
    Postal Code
    215152
    Country
    CN
    Correspondent
    Lingling Yu

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Surgeon'S Gloves KGO

    Proprietary Names

    Polyisoprene Surgical gloves

    Establishment Types

    Manufacture Medical Device