BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    QUASAR ENGINEERING LTD.

    Reg #: 3007048256 · FEI: 3007048256 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    18
    Establishment Types
    2
    Classifications
    7

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    Registration Details

    Registration Name
    QUASAR ENGINEERING LTD.
    Registration Number
    3007048256
    FEI Number
    3007048256
    Status
    Active
    Expiry Year
    2026
    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
    DEN150005

    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
    Connector, Airway (Extension) BZA
    Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction PAY
    Catheter, Peripheral, Atherectomy MCW
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Powered Laser Surgical Instrument GEX
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Cuff, Tracheal Tube, Inflatable BSK

    Proprietary Names

    Microstream luer airway adapter Newa Skin Therapy System Auryon Atherectomy System OR Auryon Atherecomy Catheter Smart OmniLine Guardian Smart SureLine Guardian Microstream EtCO2 Sampling Smart CapnoLine GuardianTM Smart Capnoline Guardian Microstream O2/Co2 Oral Nasal Filterline Microstream EtCO2 Consumables ePlus skin treatment system Advance Pediatric Oral-Nasal Filter Line With O2 Tubing/Microstream Advance Adult Oral-Nasal Filter Line With O2 Tubing/Microstream Luer Adult Oral-Nasal Sampling Line Microstream Advance Neonatal-Infant Nasal Filter Line With O2 Tubing/Microstream eTwo Skin Treatment System Cuff Pressure Manometer Microstream Luer Adult-Pediatric Intubated Sampling /line/Microstream Advance Adult-Pediatric Intubated Filter Line Profound Matrix

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device