BEUDAMED
    FDA Registration Active 🇨🇳 China

    Rapid Diagnostic Tests

    Reg #: 3009585529 · FEI: 3009585529 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    ASSURE TECH. (HANGZHOU) CO., LTD.
    Registration Number
    3009585529
    FEI Number
    3009585529
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Building 4, No. 1418-50, Moganshan Road, Gongshu District
    City
    Hangzhou Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K153465

    Owner / Operator

    Firm Name
    Assure Tech. (Hangzhou) Co., Ltd.
    Operator Number
    10040710
    Address
    Building 4, No. 1418-50, Moganshan Road, Gongshu District
    City
    Hangzhou
    State
    Zhejiang
    Postal Code
    310011
    Country
    CN
    Correspondent
    Shisheng Ling

    Products

    Device Name Product Code
    Enzyme Immunoassay, Amphetamine DKZ
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Enzyme Immunoassay, Opiates DJG

    Proprietary Names

    Rapid Diagnostic Tests Easy@Home Single Drug Screen Test (Cocaine Urine Test), EDCO-114 Areta Cocaine Test Strip (ASCOC-114)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device