BEUDAMED
    FDA Registration Active 🇨🇳 China

    ASSURE TECH. (HANGZHOU) CO., LTD.

    Reg #: 3009585529 · FEI: 3009585529 · Expires 2026
    View on FDA
    Products
    47
    Proprietary Names
    104
    Establishment Types
    4
    Classifications
    47

    Registration Details

    Registration Name
    ASSURE TECH. (HANGZHOU) CO., LTD.
    Registration Number
    3009585529
    FEI Number
    3009585529
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Building 4, No. 1418-50, Moganshan Road, Gongshu District
    City
    Hangzhou Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K252259

    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, Opiates DJG
    Enzyme Immunoassay, Phencyclidine LCM
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Enzyme Immunoassay, Amphetamine DKZ
    Enzyme Immunoassay, Cannabinoids LDJ
    Thin Layer Chromatography, Methamphetamine DJC
    Test, Methamphetamine, Over The Counter NGG
    Test, Phencyclidine (Pcp), Over The Counter NGM
    Test, Amphetamine, Over The Counter NFT
    Test, Opiates, Over The Counter NGL
    Test, Methadone, Over The Counter PTG
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Cannabinoid, Over The Counter NFW
    Test, Propoxyphene, Over The Counter QBF
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Barbiturate, Over The Counter PTH
    Test, Benzodiazepine, Over The Counter NFV
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Reagent, Coronavirus Serological QKO
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Visual, Pregnancy Hcg, Prescription Use JHI
    Test, Methadone, Employment And Insurance Testing, Exempt PVE
    Test System, Nicotine, Cotinine, Metabolites MRS
    Enzyme Immunoassay, Methadone DJR
    Gas Chromatography, Methamphetamine LAF
    Test, Methamphetamine, Employment And Insurance Testing, Exempt PVD
    Test, Morphine, Employment And Insurance Testing, Exempt PVG
    Test, Opiates, Employment And Insurance Testing, Exempt PVH
    Test, Follicle Stimulating Hormone (Fsh), Over The Counter NGA
    Test, Barbiturate, Employment And Insurance Testing, Exempt PUY
    Test, Benzodiazepine, Employment And Insurance Testing, Exempt PUZ
    Enzyme Immunoassay, Benzodiazepine JXM
    Thin Layer Chromatography, Morphine DNK
    Enzyme Immunoassay, Barbiturate DIS
    Immunoassay, Pregnanediol Glucuronide, Over The Counter QKE
    Paper, Obstetric Ph LNW
    Over-The-Counter Covid-19 Antigen Test QYT
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    Enzyme Immunoassay, Propoxyphene JXN
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt PVK
    Test, Cannabinoid, Employment And Insurance Testing, Exempt PVJ
    Test, Propoxyphene, Employment And Insurance Testing, Exempt PVI
    Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt PVA
    Test, Amphetamine, Employment And Insurance Testing, Exempt PUX
    Devices, Breath Trapping, Alcohol DJZ
    Test, Methaqualone, Employment And Insurance Testing, Exempt PVF

    Proprietary Names

    OralTox Oral Fluid Drug Test AssureTech Quick Cup Tests Areta Multi-Drug Test Cup, ACDOA-754 Areta Multi-Drug Test Cup, ACDOA-1144 AssureTech Multi-drug Urine Test Cup Blood Ketone Monitoring System for Keto Die Blood Ketone Test Strips for Keto Diet Rapid Diagnostic Tests FaStep Early Pregnancy Rapid Test Strip FaStep Early Pregnancy Rapid Test Midstream FaStep Early Pregnancy Rapid Test Cassette FaStep Pregnancy Rapid Test Cassette Fastep HCG Rapid Test Cassette Prabadin Drug Cup Test Areta Multi-Drug Screen Test, ADTP-6125B Areta Multi-Drug Screen Test, ADTP-3104 Easy@Home Cocaine Test Dip Card, EDCO-114 Areta Mutil-Drug Test Cup, ACDOA2-1134 Easy@Home Multi-Drug Screen Test Carethetic Multi Drug Test Panel Easy@Home Multi-Drug Screen Test, EDOAP-754 Easy@Home Multi-Drug Screen Test, EDOAP-3104 Areta Multi-Drug Screen Test, ADTP-254 Easy@Home Multi-Drug Screen Test, EDOAP-174 Easy@Home Multi-Drug Screen Test, EDOAP-7104 Easy@Home Drug Test Cup, ECDOA-1144A3 Areta Multi-Drug Screen Test, ADTP-1124 Carethetic Multi Drug Test Cup Easy@Home Multi-Drug Screen Test, EDOAP-144 Easy@Home Multi-Drug Screen Test, EDOAP-865 Easy@Home Single Drug Screen Test (Cocaine Urine Test), EDCO-114 Areta Mutil-Drug Test Cup, ACDOA2-2124 rapid diagnostic test Areta Mutil-Drug Test Cup, ACDOA2-3104 Identify® Diagnostics Multi-Drug Urine Test Cup Areta Multi-Drug Screen Test, ADTP-754 Easy@Home Multi-Drug Screen Test, EDOAP-6125B Easy@Home Multi-Drug Screen Test, EDOAP-1124 Easy@Home Multi-Drug Screen Test, EDOAP-254 Easy@Home Multi-Drug Screen Test, EDOAP-654 Easy@Home Multi-Drug Screen Test, EDOAP-264 Identify® Diagnostics Multi-Drug Urine Test Dip Easy@Home Drug Test Cup, ECDOA4-6125B DOA Saliva cup Prabadin Cotinine Drug Test Cassette Easy@Home Cotintine Test Dip Card Easy@Home Cotintine Test Dip Card, ECOT-115 Easy@Home Cotinine Panel Dip Test, ECOT-114 Areta Single Drug Test easy@Home Nicotine Urine Test Cotinine Test Strip Areta Cotinine Test Strip, ASCOT-114C OralTox® Oral Fluid Drug Test Combo hCG Test Prabadin HCG Pregnancy Test hCG Pregnancy Test Strip Maternova Pregnancy test Rapid Response At-Home Pregnancy Test FaStep Rapid Fentanyl Urine Test FaStep Fentanyl Rapid Test Device easy@Home Fentanyl Urine Test(Cassette), ECFY-114 Maternova Fentanyl rapid test VIVITAR laboratories THE SOLUTION HOME RAPID TEST KIT / TEST DIP CARD MULTI DRUG Rapid Response Drug Screening Panel Rapid Response Drug Screening Cup Premier Bio-Cup Tests Premier Bio-Panel Dip Tests VIVITAR laboratories THE SOLUTION HOME RAPID TEST KIT /MULTI TEST CUP Fertility Combo Rapid Test (Urine) HealCare FSH Menopause Rapid Test Easy@Home Marijuana Test Dip Card EDTH-115 Areta Marijuana Test Strip, ASTH-114C Carethetic Marijuana Test Kit (THC urine test) Easy@Home Single Drug Screen Test (Marijuana Urine Test), EDTH-114 VIVITAR laboratories THE SOLUTION HOME RAPID TEST KIT/PHENCYCLIDINE TEST STRIP VIVITAR laboratories THE SOLUTION HOME RAPID TEST KIT/METHAMPHETAMINE TEST STRIP Easy@Home Multi-Drug Screen Test, EDOAP-124 VIVITAR laboratories THE SOLUTION HOME RAPID TEST KIT/MARIJUANA TEST STRIP Easy@Home Marijuana Test Strips, ESTH-115 Easy@Home Marijuana Test Cup, ECTH4-114A3 Easy@Home Marijuana Test Strip Areta Cocaine Test Strip (ASCOC-114) PdG Rapid Test Vaginal pH Test Device Fastep COVID-19 Antigen Pen Test Fastep COVID-19 Antigen Pen Home Test FaStep Pregnancy Rapid Test Strip FaStep Pregnancy Rapid Test Midstream EASY@HOME PREGNANCY TEST, EZW1-MD ASSURETECH DOA DIPSTICK SCREEN PANEL TESTS ASSURETECH DOA INTEGRATED CUP TESTS LH One Step Ovulation Test Digital Fertility Tracker Digital Fertility Testing System Digital LH Test HealCare LH Ovulation Rapid Test Easy@Home Ovulation Test, EZW2-S Rapid Response Pregnancy Test 20mIU Breath Alcohol Test CertiCheck Multi Drug Panel Dip Test AssureTech Panel Dip Tests Multi-Panel Drug Test Cup Ecotest ® Multi-Drug Panel Dip Tests AssureTech Multi-drug Urine Test Panel

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility