BEUDAMED
    FDA Registration Active 🇨🇳 China

    SUZHOU MELODICARE MEDICAL TECHNOLOGY CO., LTD

    Reg #: 3016864576 · FEI: 3016864576 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    SUZHOU MELODICARE MEDICAL TECHNOLOGY CO., LTD
    Registration Number
    3016864576
    FEI Number
    3016864576
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Room 301, Building F2, No. 32 Hongxi road, Suzhou high-tech zone,Jiangsu province.
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K191283

    Owner / Operator

    Firm Name
    Suzhou Melodicare Medical Technology Co., Ltd
    Operator Number
    10069005
    Address
    Building Room 301, no. 32 Hongxi road, Suzhou high-tech zone
    City
    Suzhou
    State
    Jiangsu
    Postal Code
    215151
    Country
    CN
    Correspondent
    Fay Zou

    US Agent

    Business Name
    RGLM Consulting LLC
    Contact Name
    Roy Zhang
    Address
    6113 Swift Current Way
    City
    Clarksville
    State
    MD
    ZIP
    21029
    Country
    US
    Email
    [email protected]
    Phone
    425 2364274

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL
    Stethoscope, Electronic DQD
    Mask, Surgical FXX

    Proprietary Names

    Infrared Thermometer, model Breeze-20 Infrared Thermometer, model Breeze Electronic Stethoscope,model:iSteso-D2 Electronic Stethoscope,model:smartho-D2 Surgical Mask

    Establishment Types

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