BEUDAMED
    FDA Registration Active 🇨🇳 China

    Andon Medical co., LTD

    Reg #: 3008573045 · FEI: 3008573045 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    68
    Establishment Types
    2
    Classifications
    17

    Registration Details

    Registration Name
    Andon Medical co., LTD
    Registration Number
    3008573045
    FEI Number
    3008573045
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    NO.26 HANGYU ROAD, TIANJIN AIRPORT ECONOMIC AREA, TIANJIN , TIANJIN , 300381 , CHINA
    City
    Tianjin
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K251085

    Owner / Operator

    Firm Name
    ANDON MEDICAL CO.,LTD
    Operator Number
    10033742
    Address
    No.26 Hangyu Road,, Tianjin Airport Economic Area
    City
    TIANJIN
    State
    CN-TJ
    Postal Code
    300381
    Country
    CN
    Correspondent
    Guijun Ren

    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, Measurement, Blood-Pressure, Non-Invasive DXN
    Clinical Electronic Thermometer SDV
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
    Stimulator, Electrical, Transcutaneous, For Arthritis NYN
    Blood Pressure Cuff DXQ
    Coronavirus Antigen Detection Test System. QKP
    Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch OSG
    System, Test, Blood Glucose, Over The Counter NBW
    Oximeter DQA
    Oximeter, Infrared, Sporting, Aviation OCH
    Covid-19 Multi-Analyte Antigen Device QMN
    Irrigator, Powered Nasal KMA
    Analyzer, Body Composition, Exempt PUH
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Glucose Dehydrogenase, Glucose LFR
    Multi-Analyte Respiratory Virus Antigen Detection Test SCA
    Over-The-Counter Covid-19 Antigen Test QYT

    Proprietary Names

    iHealth (model: PT9L) iHealth (model: PT1) Infrared Digital No-Touch Thermometer (model:PT2L) iHealth (model: PT3SBT) iHealth (model: PT3) Infrared No-Touch Forehead Thermometer (model:PT9L) iHealth (model: PT2L) iHealth Infrared No-Touch Forehead Thermometer (model:PT9S) iHealth(model: AD-2126) SmartHeart (model: 01-5811) SmartHeart (model: 01-5812) SmartHeart (model: 01-5817) Exchange Select (model: 88-554) amazon basic+care (model: 44-553) Good Neighbor (model: 90-554) SmartHeart (model: 01-554) SmartHeart (model: 01-5811T) iHealth Jurni Connected Blood Pressure Monitor (Model: BP-300CL) good neighbor (model: 90-553) SmartHeart (model: 01-539WR) iHealth Track Pro Connected Blood Pressure Monitor (Model: KN-550LT) Meijer (model: 74-553) TOP CARE (model: 52-553) Meijer (model: 74-554) SmartHeart (model: 01-553NP) SmartHeart (model: 01-553) SmartHeart (model: 01-539) Discount Drug (model: 71-553) Best Choice (model: 41-553) Exchange Select (model: 88-553) Care One (model: 67-553) Discount Drug (model: 71-554) Wrist Blood Pressure Monitor, Blood Pressure Monitor(KD-752) Quality Choice(model: 89-743T) SmartHeart(model: 01-743T) Insect Bite Healer (model: IBH-1000) IHEALTH FINGERTIP PULSE OXIMETER(PO3M) iHealth (model: BP5S) iHealth (model: PO3) PULSE OXIMETER (model: PO6) PULSE OXIMETER (model: PO6L) iHealth (model: BPM1) iHealth (model: KD-723) iHealth COVID-19/Flu A&B Rapid Test amazon basic+care (model: 44-541) SmartHeart (model: 01-541) TOP CARE(model: 52-541) WRIST BLOOD PRESSURE MONITOR (model: KD-7920) Exchange Select(model: 88-541) iHealth Fresh Electric Nasal Wash System (model: ANC1) iHealth BP3L Wireless Blood Pressure Monitor iHealth (model: BP7S) ARM BLOOD PRESSURE MONITOR (model: KD-5920TL) iHealth (model: HS2S Pro) iHealth Nexus (Model: HS2S) SmartHeart(model: 01-540) iHealth Early Pregnancy Test Strip iHealth Early Pregnancy Test AG-607 Multi Blood Glucose Monitoring System AG-607 Blood Glucose Monitoring System MEDLINE(model: MDS8001B) iHealth Accu Connected Blood Pressure Monitor (model: KD-5811BT) iHealth Accu Luminate Connected Blood Pressure Monitor (model: KD-5811BT) MEDLINE(model: MDS8001BXL) iHealth Flu A&B/COVID-19/RSV Rapid Test (model: ICR-3000) iHealth Flu A&B/COVID-19/RSV Rapid Test Pro Control Kit iHealth COVID-19 Antigen Rapid Test Equate Covid-19 Test Kit Single

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device