BEUDAMED
    FDA Registration Active 🇨🇳 China

    TracCollar

    Reg #: 3012727645 · FEI: 3012727645 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Opack Industry Co., Ltd
    Registration Number
    3012727645
    FEI Number
    3012727645
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No 64, Zhuangcun Rd, Shajing, Baoan
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K172875

    Owner / Operator

    Firm Name
    Opack Industry Co., Ltd.
    Operator Number
    10085521
    Address
    No 64, Zhuangcun Road, Shajing, Baoan
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518125
    Country
    CN

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Dr
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Ventilator, Continuous, Facility Use CBK
    Continuous, Ventilator, Home Use NOU

    Proprietary Names

    TracCollar

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)