BEUDAMED
    FDA Registration Active 🇨🇳 China

    Areta Multi-Drug Screen Test, ADTP-1124

    Reg #: 3009585529 · FEI: 3009585529 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    30
    Establishment Types
    3
    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
    K180349

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

    Proprietary Names

    Areta Multi-Drug Screen Test, ADTP-1124 Prabadin Drug Cup Test Easy@Home Multi-Drug Screen Test rapid diagnostic test Carethetic Multi Drug Test Panel Easy@Home Multi-Drug Screen Test, EDOAP-1124 Areta Mutil-Drug Test Cup, ACDOA2-1134 Easy@Home Multi-Drug Screen Test, EDOAP-654 Easy@Home Multi-Drug Screen Test, EDOAP-754 Easy@Home Multi-Drug Screen Test, EDOAP-865 Easy@Home Multi-Drug Screen Test, EDOAP-264 Areta Mutil-Drug Test Cup, ACDOA2-2124 Areta Mutil-Drug Test Cup, ACDOA2-3104 Easy@Home Multi-Drug Screen Test, EDOAP-174 Easy@Home Drug Test Cup, ECDOA-1144A3 Areta Multi-Drug Screen Test, ADTP-754 Easy@Home Cocaine Test Dip Card, EDCO-114 Areta Multi-Drug Screen Test, ADTP-3104 Easy@Home Multi-Drug Screen Test, EDOAP-7104 Areta Multi-Drug Screen Test, ADTP-254 Rapid Diagnostic Tests Areta Multi-Drug Screen Test, ADTP-6125B Easy@Home Multi-Drug Screen Test, EDOAP-6125B Identify® Diagnostics Multi-Drug Urine Test Cup Carethetic Multi Drug Test Cup Easy@Home Multi-Drug Screen Test, EDOAP-144 Easy@Home Multi-Drug Screen Test, EDOAP-254 Easy@Home Multi-Drug Screen Test, EDOAP-3104 Identify® Diagnostics Multi-Drug Urine Test Dip Easy@Home Single Drug Screen Test (Cocaine Urine Test), EDCO-114

    Establishment Types

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