BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    Smart SureLine Guardian

    Reg #: 3007048256 · FEI: 3007048256 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    QUASAR ENGINEERING LTD.
    Registration Number
    3007048256
    FEI Number
    3007048256
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Flat B1, 10/F, Yeung Yiu Chung No.6 Industrial Bldg, 19 Cheung Shun St, Cheung Sha Wan
    City
    Kowloon
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K093388

    Owner / Operator

    Firm Name
    Quasar Engineering Ltd.
    Operator Number
    10025822
    Address
    Flat B1, 10/F, Yeung Yiu Chung No.6 Industrial Bldg, 19 Cheung Shun St, Cheung Sha Wan
    City
    Kowloon
    State
    HK-NOTA
    Postal Code
    NONE
    Country
    HK

    US Agent

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

    Products

    Device Name Product Code
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK

    Proprietary Names

    Smart SureLine Guardian Smart OmniLine Guardian Microstream EtCO2 Sampling Smart CapnoLine GuardianTM Smart Capnoline Guardian

    Establishment Types

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