BEUDAMED
    FDA Registration Active 🇨🇳 China

    AssureTech Multi-drug Urine Test Panel

    Reg #: 3009585529 · FEI: 3009585529 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    11

    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
    K243996

    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
    Test, Methamphetamine, Over The Counter NGG
    Test, Barbiturate, Over The Counter PTH
    Test, Amphetamine, Over The Counter NFT
    Test, Benzodiazepine, Over The Counter NFV
    Test, Phencyclidine (Pcp), Over The Counter NGM
    Test, Propoxyphene, Over The Counter QBF
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Cannabinoid, Over The Counter NFW
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Methadone, Over The Counter PTG
    Test, Opiates, Over The Counter NGL

    Proprietary Names

    AssureTech Multi-drug Urine Test Panel AssureTech Quick Cup Tests Ecotest ® Multi-Drug Panel Dip Tests CertiCheck Multi Drug Panel Dip Test Identify® Diagnostics Multi-Drug Urine Test Cup Multi-Panel Drug Test Cup AssureTech Panel Dip Tests AssureTech Multi-drug Urine Test Cup Identify® Diagnostics Multi-Drug Urine Test Dip

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device