BEUDAMED
    FDA Registration Active 🇨🇳 China

    COTRONIC TECHNOLOGY LIMITED

    Reg #: 3004215929 · FEI: 3004215929 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    14
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    COTRONIC TECHNOLOGY LIMITED
    Registration Number
    3004215929
    FEI Number
    3004215929
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Floor 4-6, Block 7, West of ZhouShi Road, XiXiang Street, BaoAn Zone
    City
    SHENZHEN, GUANG DONG PROVINCE Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K120671

    Owner / Operator

    Firm Name
    COTRONIC TECHNOLOGY LIMITED
    Operator Number
    9057884
    Address
    FLOOR 4, BLOCK 4, FU YUAN IND, ZONE,JIU WEI,XING XIANG, BAO AN
    City
    SHEN ZHEN
    State
    Guangdong
    Postal Code
    518126
    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
    Syringe, Irrigating (Non Dental) KYZ
    Irrigator, Powered Nasal KMA
    Continuous Measurement Thermometer FLL
    Dilator, Rectal FFP
    Clinical Electronic Thermometer SDV

    Proprietary Names

    Nasal Aspirator ASPI, ASPI 2, ASPI 3, ASPI 4, ASPI 5, ASPI-V Nasal Irrigation NI01, NI02, NI03, NI04, NI05, NI06, NI07, NI08, NI09, NI10 Digital soother thermometer model TM03 CR01, CR02, CR03, CR04, CR05, CR06, CR07, CR08, CR09, CR10 Gas Evacuation Tube DIGITAL ELECTRONIC THERMOM TM01, TM02/ TM08, TM09S, TM12FE, TM12F, MT804, TM13 Clinical Electronic Thermometer Model TM22 Clinical Electronic Thermometer Model TM12 & TM21 Digital Soother Thermometer model TM03 Clinical Electronic Thermometer Model TM12 & TM21; TM22 TM01, TM02, TM03, TM08, TM09S, TM12, TM21, TM22, MT201, MT803, MT804

    Establishment Types

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