BEUDAMED
    FDA Registration Active 🇨🇳 China

    Self Sealing Sterilization Pouches

    Reg #: 3017910185 · FEI: 3017910185 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    HUBEI GUARDDENT MEDICAL TECHNOLOGY CO.,LTD
    Registration Number
    3017910185
    FEI Number
    3017910185
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 24-29th, 2/F, No. 11 Block, No.1 Guiyuan Temple South Road, Hanyang District
    City
    Wuhan Hubei
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K162258

    Owner / Operator

    Firm Name
    Hubei Guarddent Medical Technology Co.,Ltd
    Operator Number
    10078958
    Address
    Room 24-29th, 2/F, No. 11 Block, No.1 Guiyuan Temple South Road, Hanyang District
    City
    Wuhan City
    State
    Hubei
    Postal Code
    430070
    Country
    CN
    Correspondent
    Qin Hu

    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
    Wrap, Sterilization FRG

    Proprietary Names

    Self Sealing Sterilization Pouches

    Establishment Types

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