BEUDAMED
    FDA Registration Active 🇨🇳 China

    ANDON HEALTH CO., LTD

    Reg #: 3003741676 · FEI: 3003741676 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    68
    Establishment Types
    3
    Classifications
    16

    Registration Details

    Registration Name
    ANDON HEALTH CO., LTD
    Registration Number
    3003741676
    FEI Number
    3003741676
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 3 Jin Ping Street,Ya An Road,, NANKAI DISTRICT
    City
    TIANJIN
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K153561

    Owner / Operator

    Firm Name
    ANDON HEALTH CO.,LTD
    Operator Number
    9055208
    Address
    No. 3 Jin Ping Street,Ya An Road,, NANKAI DISTRICT
    City
    TIANJIN
    State
    CN-NOTA
    Postal Code
    300190
    Country
    CN
    Correspondent
    YI - LIU

    US Agent

    Business Name
    IHEALTH LABS, INC
    Contact Name
    Yange Wang
    Address
    880 W MAUDE AVE,SUNNYVALE , CALIFORNIA , 94085 , UNITED STATES
    City
    Sunnyvale
    State
    CA
    ZIP
    94085
    Country
    US
    Email
    [email protected]
    Phone
    408 6638349

    Products

    Device Name Product Code
    System, Test, Blood Glucose, Over The Counter NBW
    Glucose Dehydrogenase, Glucose LFR
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Analyzer, Body Composition MNW
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
    Stimulator, Electrical, Transcutaneous, For Arthritis NYN
    Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch OSG
    Oximeter DQA
    Multiple Use Blood Lancet For Single Patient Use Only QRL
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    Blood Pressure Cuff DXQ
    Analyzer, Body Composition, Exempt PUH
    Irrigator, Powered Nasal KMA
    Clinical Electronic Thermometer SDV
    Oximeter, Infrared, Sporting, Aviation OCH

    Proprietary Names

    AG-607 Multi Blood Glucose Monitoring System iHealth Acacia Blood Glucose Monitoring System (model:AG-607) iHealth Early Pregnancy Test Strip iHealth Early Pregnancy Test iHealth Cloud iHealth BP3L Wireless Blood Pressure Monitor iHealth (model: BP7S) MEDLINE(model: MDS8001BXL) iHealth Accu Luminate Connected Blood Pressure Monitor (model: KD-5811BT) MEDLINE(model: MDS8001B) iHealth Accu Connected Blood Pressure Monitor (model: KD-5811BT) Wrist Blood Pressure Monitor, Blood Pressure Monitor(KD-752) SmartHeart(model: 01-743T) Quality Choice(model: 89-743T) iHealth Soothe Dual-Channel TENS Unit (model:AD-2126) iHealth(model: AD-2126) Insect Bite Healer (model: IBH-1000) iHealth Track Blood Pressure Monitor IHEALTH FINGERTIP PULSE OXIMETER(PO3M) SmartHeart(model: 01-540) SmartHeart (model: 01-5811) SmartHeart (model: 01-5812) SmartHeart (model: 01-5817) iHealth Myvitals iHealth (model: BPM1) ARM BLOOD PRESSURE MONITOR (model: KD-5920TL) Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor(KD-552) iHealth Neo Wireless Blood Pressure Monitor(model: BP5S) iHealth (model: HS2S Pro) iHealth Nexus (Model: HS2S) iHealth Push Wrist Blood Pressure Monitor (model: KD-723) iHealth Fresh Electric Nasal Wash System (model: ANC1) SmartHeart (model: 01-541) TOP CARE(model: 52-541) Exchange Select(model: 88-541) WRIST BLOOD PRESSURE MONITOR (model: KD-7920) amazon basic+care (model: 44-541) iHealth (model: PT3SBT) iHealth (model: PT3) iHealth (model: PT1) iHealth (model: PT2L) Infrared Digital No-Touch Thermometer (model: PT2L) INFRARED NO-TOUCH FOREHEAD THERMOMETER (model: PT9L) iHealth Infrared No-Touch Forehead Thermometer (model:PT9S) iHealth(model: PT9L) iHealth (model: PO3) PULSE OXIMETER (model: PO6) PULSE OXIMETER (model: PO6L) TOP CARE (model: 52-553) good neighbor (model: 90-553) SmartHeart (model: 01-5811T) Best Choice (model: 41-553) Discount Drug (model: 71-554) Good Neighbor (model: 90-554) Exchange Select (model: 88-553) SmartHeart (model: 01-539WR) Discount Drug (model: 71-553) Care One (model: 67-553) iHealth Track Pro Connected Blood Pressure Monitor(Model: KN-550LT) SmartHeart (model: 01-553) Meijer (model: 74-553) SmartHeart (model: 01-553NP) SmartHeart (model: 01-554) Exchange Select (model: 88-554) SmartHeart (model: 01-539) amazon basic+care (model: 44-553) iHealth Jurni Connected Blood Pressure Monitor (Model: BP-300CL) Meijer (model: 74-554)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device