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    FDA Registration Active 🇨🇳 China

    Guangzhou Daxin Health Technology (Dongguan) Co., Ltd

    Reg #: 3019470217 · FEI: 3019470217 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    42
    Establishment Types
    3
    Classifications
    7

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    Registration Details

    Registration Name
    Guangzhou Daxin Health Technology (Dongguan) Co., Ltd
    Registration Number
    3019470217
    FEI Number
    3019470217
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Room 601, Building 3, No. 9, Jinshagang Road 1, Dalang Town
    City
    Dongguan City Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K161938

    Owner / Operator

    Firm Name
    Guangzhou Daxin Health Technology Co., Ltd
    Operator Number
    10081835
    Address
    Room 510, Building A02, Guangzhou Knowledge City International Leading Talent Agglomeration Area, No. 5 Suike Street, Huangpu District
    City
    Guangzhou
    State
    Guangdong
    Postal Code
    510530
    Country
    CN

    US Agent

    Business Name
    IRC USA
    Contact Name
    Charles Mack
    Address
    2950 E Lindrick Dr.
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Oximeter DQA
    Analyzer, Body Composition, Exempt PUH
    Continuous Measurement Thermometer FLL
    Dispenser, Solid Medication NXB
    Clinical Electronic Thermometer SDV
    Massager, Therapeutic, Electric ISA

    Proprietary Names

    Blood Pressure Meter MS1 Fingertip Pulse Oximeter Body Composition Scale EF-651B4,EF-654B4,EF-655B4,EF-670B4,EF-706B4,EF-802B4,EF-916B4,eF-706B4S,eF-918B4PL,eF-917B4P,eF-804B4P,eF-919B4,eF-919B4S,T9140 eF-804B4P-Tuya,eF-916B4S,eF-919B4P,eF-919B4SP,eF-706W,eF-804W,GN-WA005-199,eF-654W,eF-655W,eF-670W,eF-802W,eF-803W,eF-805W eF-806W,eF-807W,eF-916W,eF-917W,eF-918W,eF-917WP,WW390XF,Koogeek-S1,WW390F,SF-371,S-3 EF-803B4,EF-804B4,EF-805B4,EF-806B4,EF-807B4,EF-914B4,EF-915B4,EF-917B4,eF-914B4P,eF-712B4,eF-671B4,eF-918B4P,eF-918B4SP,eF-804B4SP BFS1 LAH5CB4-BT Thermometer MT1, TE-66 Infrared Thermometer T30, TE-82, TE-79, TE-102 EQ-HW-PB-200-CR/YH001 EQ-HW-PB-270-CR/YH004 EQ-HW-PB-250-CR/YH002 DXYH-006 EQ-HW-PB-700-AC/YH008 YH007-1 YH005-02 DXYH-019 DXYH-012 BD-HW-PB-500-AC/YH006 DXYH-003 DXYH-009 DXYH-005 Pill Planner; Pill Dispensor DXYH-004 DXYH-016 DXYH-018 BD-HW-PB-900-AC/YH007 BD-HW-PB-800-AC/YH005 DXYH-001 DXYH-002 Z11A-BT, Z12A-BT, Z13A-BT DXYH-010 DXYH-008 CLINICAL ELECTRONIC THERMOMETER T30,TE-82,TE-79,TE-102,EQ-HW-TH-500-BK,MT1,TE-66,B-FT102 EYE MASSAGER DX-206,DX-207,DX-208,DX-300.DX-301,DX-302

    Establishment Types

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