BEUDAMED
    FDA Registration Active 🇨🇳 China

    TWINLOTUS

    Reg #: 3003999964 · FEI: 3003999964 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DALIAN LATEX CO LTD
    Registration Number
    3003999964
    FEI Number
    3003999964
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 18, Haixing Road,Pulandian District
    City
    Dalian Liaoning
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K081413

    Owner / Operator

    Firm Name
    Dalian Latex Co Ltd
    Operator Number
    10027528
    Address
    No. 18, Haixing Road,Pulandian District
    City
    Dalian
    State
    Liaoning
    Postal Code
    116200
    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
    Condom HIS

    Proprietary Names

    TWINLOTUS SHIELDS KAPEET KAPOOT MALE LATEX CONDOM NACH KODEX NACH Blowdom Trunk Presa Skins Plain/Ribbed/Dotted/Rib&Dot/Physical Delay/Comfort,condoms

    Establishment Types

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