BEUDAMED
    FDA Registration Active 🇨🇳 China

    REGULATOR ASSEMBLY FOR 800 EV2

    Reg #: 3003781173 · FEI: 3003781173 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD
    Registration Number
    3003781173
    FEI Number
    3003781173
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No 4 and No 8 Plants 9 Shenghui South Road, Nantou Town
    City
    Zhongshan City Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K071607

    Owner / Operator

    Firm Name
    Zhongshan A&E Machinery Industry Co., LTD
    Operator Number
    10049449
    Address
    No 4 and No 8 Plants 9 Shenghui South Rd, Nantou Town
    City
    Zhongshan City
    State
    Guangdong
    Postal Code
    510000
    Country
    CN

    US Agent

    Business Name
    Regulatory Insight, Inc.
    Contact Name
    Kevin Walls
    Address
    33 Golden Eagle Lane
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Pump, Portable, Aspiration (Manual Or Powered) BTA

    Proprietary Names

    REGULATOR ASSEMBLY FOR 800 EV2 FILTERS FOR VACUTEC 800 EV2 NUT FLTR FOR VACUTEC 800 EV2 COLLECTION BOTTLE FOR 800 EV2 REPLACMENT HANDLE FOR 800 EV2 SUCTION RUBBER FEET FOR 800 EV CONNECTION TUBING FOR 800 EV2 ASPIRATOR VACUTEC 800 EV2 REPLACEMENT BOTTLE HOLDER EV2 SUCTION TUBE FOR 800 EV2

    Establishment Types

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