BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHENZHEN AIRGLE CORPORATION LIMITED

    Reg #: 3015139810 · FEI: 3015139810 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    SHENZHEN AIRGLE CORPORATION LIMITED
    Registration Number
    3015139810
    FEI Number
    3015139810
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Zone A&B, The 11th Floor, KeChuang Building, QuanZhi Science & Technology Innovation Park, Houting Maozhoushan Industrial Park, ShaJing Street, Baoan District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K232645

    Owner / Operator

    Firm Name
    SHENZHEN AIRGLE CORPORATION LIMITED
    Operator Number
    10059006
    Address
    Zone A&B, The 11th Floor, KeChuang Building, QuanZhi Science & Technology Innovation Park, Houting Maozhoushan Industrial Park,ShaJing Street, Baoan District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518000
    Country
    CN
    Correspondent
    Jerry Liu

    Products

    Device Name Product Code
    Purifier, Air, Ultraviolet, Medical FRA
    Mask, Gas, Anesthetic BSJ
    Saw, Manual And Accessories GDR
    Disinfectant, Medical Devices LRJ

    Proprietary Names

    Airgle Room Air Purifier, Models: AG300, AG300S, AG300L, AG300E, AG320, AG320S, AG320L, AG320E Airgle Clean Room Air Purifier, Models: AG900, AG900S, AG900L, AG900E, AG930, AG930S, AG930L, AG930E Airgle Room Air Purifier, Models: AG600, AG600S, AG600L, AG600E, AG700, AG700S, AG700L, AG700E Airgle Face Mask, Models: AM120, AM120M, AM120W, AM120B, AM120G, AM100, AM100S, AM100M, AM100L Airgle Extraoral Dental Smart FlexHose, Models: AG600D, AG900D Airgle Commercial Ventilation System, Models: AG2000, AG3000 Airgle Personal Air Purifier, Models: AG25, AG35 Airgle Fresh Air Ventilation System, Models: AG2000

    Establishment Types

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