BEUDAMED
    FDA Registration Active 🇨🇳 China

    DONGGUAN E-TEST TECHNOLOGY CO.,LTD

    Reg #: 3017896172 · FEI: 3017896172 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    11
    Establishment Types
    4
    Classifications
    3

    Registration Details

    Registration Name
    DONGGUAN E-TEST TECHNOLOGY CO.,LTD
    Registration Number
    3017896172
    FEI Number
    3017896172
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Room 201, 301, Building 1, Changping Section No.1, Dongshen Road, Changping Town
    City
    Dongguan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K250231

    Owner / Operator

    Firm Name
    DONGGUAN E-TEST TECHNOLOGY CO.,LTD
    Operator Number
    10079208
    Address
    Room 201, 301, Building 1, Changping Section No.1, Dongshen Road, Changping Town
    City
    Dongguan
    State
    Guangdong
    Postal Code
    523570
    Country
    CN
    Correspondent
    Victor Wan

    US Agent

    Business Name
    SHARE INFO INC.
    Contact Name
    Clare Ho
    Address
    3557 158th St Flushing, NY
    City
    Flushing
    State
    NY
    ZIP
    11358
    Country
    US
    Email
    [email protected]
    Phone
    929 4102964

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Continuous Measurement Thermometer FLL
    Strip, Temperature, Forehead, Liquid Crystal KPD

    Proprietary Names

    Automatic Upper Arm Blood Pressure Monitor (Model: BA-836, BA-839, BA-840, BA-856, BPU311) Automatic Upper Arm Blood Pressure Monitor (Model: BA 845X, BA-847X, BA-849X, BA-851X, BA-852X, BA 855X, BA-835) Automatic Upper Arm Blood Pressure Monitor (Model: BA-831X, BA-832X, BA 833X, BA-837X, BA-838X, BA-842X, BA-843X) Digital Thermometer (Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) Automatic Upper Arm Blood Pressure Monitor (model: BA-821X, BA-822X, BA-823X, BA-826X, BA-818, BA-819, 1001e, MDS1001UE) Automatic Upper Arm Blood Pressure Monitor (model :BA-801X, BA-802X, BA-803X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813 Automatic Upper Arm Blood Pressure Monitor (model: MDS1001, MDS1001U, MDS1001UT, MDS1001CS) Automatic Upper Arm Blood Pressure Monitor (model: BA-832X) Automatic Upper Arm Blood Pressure Monitor (model: MDS4001, MDS4001LA, MDS4001LAT, MDS4001PLUS, MDS5001) Automatic Upper Arm Blood Pressure Monitor (model: BA-815, BA-816) Forehead thermometer strips, model: MDSTS101

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Foreign Private Label Distributor Complaint File Establishment per 21 CFR 820.198