BEUDAMED
    FDA Registration Active 🇨🇳 China

    Autoclave Indicator Tape; EO Indicator Tape

    Reg #: 3035856230 · FEI: 3035856230 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    JIANGMEN NEW ERA EXTERNAL DRUG USE CO., LTD.
    Registration Number
    3035856230
    FEI Number
    3035856230
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.8 Beiyuan Rd, Jianghai District
    City
    Jiangmen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K241036

    Owner / Operator

    Firm Name
    Jiangmen New Era External Drug Use Co., Ltd.
    Operator Number
    10092452
    Address
    No.8 Beiyuan Rd, Jianghai District
    City
    Jiangmen
    State
    Guangdong
    Postal Code
    529000
    Country
    CN
    Correspondent
    Yingxuan Mu

    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
    Indicator, Physical/Chemical Sterilization Process JOJ

    Proprietary Names

    Autoclave Indicator Tape; EO Indicator Tape

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device