BEUDAMED
    FDA Registration Active 🇨🇳 China

    Easy@Home Multi-Drug Screen Test, EDOAP-124

    Reg #: 3009585529 · FEI: 3009585529 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    12
    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
    K161044

    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
    Thin Layer Chromatography, Methamphetamine DJC
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Phencyclidine LCM

    Proprietary Names

    Easy@Home Multi-Drug Screen Test, EDOAP-124 VIVITAR laboratories THE SOLUTION HOME RAPID TEST KIT/MARIJUANA TEST STRIP Carethetic Marijuana Test Kit (THC urine test) Areta Marijuana Test Strip, ASTH-114C Rapid Diagnostic Tests VIVITAR laboratories THE SOLUTION HOME RAPID TEST KIT/METHAMPHETAMINE TEST STRIP Easy@Home Single Drug Screen Test (Marijuana Urine Test), EDTH-114 VIVITAR laboratories THE SOLUTION HOME RAPID TEST KIT/PHENCYCLIDINE TEST STRIP Easy@Home Marijuana Test Strips, ESTH-115 Easy@Home Marijuana Test Dip Card EDTH-115 Easy@Home Marijuana Test Cup, ECTH4-114A3 Easy@Home Marijuana Test Strip

    Establishment Types

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