BEUDAMED
    FDA Registration Active 🇨🇳 China

    WENZHOU RENHUA INSTRUMENTS CO.,LTD

    Reg #: 3015220324 · FEI: 3015220324 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    23
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    WENZHOU RENHUA INSTRUMENTS CO.,LTD
    Registration Number
    3015220324
    FEI Number
    3015220324
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3rd Floor, Building 2, No.1099 Kunbei Road, Lingkun Street, Wenzhou Marine Economic Development Demonstration Zone
    City
    WENZHOU Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K190902

    Owner / Operator

    Firm Name
    WENZHOU RENHUA INSTRUMENTS CO.,LTD
    Operator Number
    10059735
    Address
    3rd Floor, Building 2, No.1099 Kunbei Road, Lingkun Street, Wenzhou Marine Economic Development Demonstration Zone
    City
    Wenzhou
    State
    Zhejiang
    Postal Code
    325026
    Country
    CN
    Correspondent
    SAIJIE Wang

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Light, Examination, Medical, Battery Powered KYT
    Otoscope ERA
    Stethoscope, Manual LDE
    Blood Pressure Cuff DXQ

    Proprietary Names

    Diagnostic pen light Diagnostic pen light for SPHYGMOMANOMETER DIAGNOSIS KITS, Model MAX0206 Otoscope (RH7001) Blood Pressure Meter Model Max0203 (Blue, Pink, green, gray, red, violet, yellow or Black cuff), SPHYGMOMANOMETER DIAGNOSIS KITS, Model MAX0206, Blood Pressure Meter Model Max02 (Blue, Pink, green, gray, red, violet, yellow or Black cuff), Blood Pressure Meter Model Max0202((Blue, Pink, green, gray, red, violet, yellow or Black cuff) Blood Pressure Meter Model Max0201 (Blue, Pink, green, gray, red, violet, yellow or Black cuff), Stethoscope for Blood Pressure Meter Model Max0201 RH3012 DUAL HEAD STETHOSCOPE Stethoscope for Blood Pressure Meter Model Max0202 NYLON CARRY BAG, NYLON CASE RH3001 SINGLE HEAD STETHOSCOPE RH3009 SINGLE HEAD STETHOSCOPE Stethoscope for Blood Pressure Meter Model Max0203 RH3002 DUAL HEAD STETHOSCOPE RH3007 Stainless steel stethoscope RH3004 Pediatric dual head stethoscope RH3008 Teaching type stethoscope Stethoscope for SPHYGMOMANOMETER DIAGNOSIS KITS, model MAX0206 RH3003 Rappaport stethoscope RH3005 Infant stethoscope RH3006 Stainless steel stethoscope

    Establishment Types

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