BEUDAMED
    FDA Registration Active 🇨🇳 China

    Easy Healthcare Corporation, Easy@Home Multi-Drug Screen Test

    Reg #: 3023322455 · FEI: 3023322455 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    80
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    GUANGZHOU WONDFO BIOTECH CO., LTD.
    Registration Number
    3023322455
    FEI Number
    3023322455
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 268, Shenzhou Road, Huangpu District
    City
    Guangzhou Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K202567

    Owner / Operator

    Firm Name
    GUANGZHOU WONDFO BIOTECH CO., LTD.
    Operator Number
    9064561
    Address
    No.8 lizhishan Road, Science City, Huangpu District, 510663
    City
    GUANGZHOU
    State
    Guangdong
    Postal Code
    510663
    Country
    CN
    Correspondent
    Jihua - Wang

    US Agent

    Business Name
    LSI International Inc.
    Contact Name
    Joe Shia
    Address
    504 East Diamond Ave., Suite I
    City
    Gaithersburg
    State
    MD
    ZIP
    20877
    Country
    US
    Email
    [email protected]
    Phone
    240 5057880

    Products

    Device Name Product Code
    Test, Methadone, Over The Counter PTG
    Test, Barbiturate, Over The Counter PTH
    Test, Amphetamine, Over The Counter NFT
    Test, Opiates, Over The Counter NGL
    Test, Methamphetamine, Over The Counter NGG
    Test, Propoxyphene, Over The Counter QBF
    Test, Benzodiazepine, Over The Counter NFV
    Enzyme Immunoassay, Phencyclidine LCM
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Cannabinoid, Over The Counter NFW
    Test, Tricyclic Antidepressants, Over The Counter QAW

    Proprietary Names

    Easy Healthcare Corporation, Easy@Home Multi-Drug Screen Test SAFElife™ T-Dip Cocaine (COC) Urine Test Panel Easy@Home® Multi-Drug Screen Test, EDOAP-6125B Easy@Home® Multi-Drug Screen Test, EDOAP-254 SAFElife™ T-Dip Cocaine (COC150) Urine Test Panel SAFElife™ T-Dip Cocaine (COC) Urine Test Panel Rx SAFElife™ T-Dip Methamphetamine (MET500/mAMP500) Urine Test Panel Rx Easy@Home® Multi-Drug Screen Test, EDOAP-3104 SAFElife™ T-Dip Methylenedioxymethamphetamine (MDMA) Urine Test Panel Rx SAFElife™ T-Dip Morphine (MOP) Urine Test Panel ONCORE DETOX Single Drug Dip Card (AMP) SAFElife™ T-Dip Cannabinoids (THC) Urine Test Panel SAFElife™ T-Dip Nortriptyline (TCA) Urine Test Panel Rx Mintegrity® Multi-Panel Urine Test Easy@Home® Multi-Drug Screen Test, EDOAP-7104 SAFElife™ T-Dip Amphetamine (AMP500) Urine Test Panel Rx SAFElife™ T-Dip Oxazepam (BZO) Urine Test Panel Rx SAFElife™ T-Dip Secobarbital (BAR) Urine Test Panel Rx iSCREEN™ Urine Test Dx Drug Screen Dip Card (Morphine (MOP)) SAFElife™ T-Dip Morphine (OPI) Urine Test Panel Rx ONCORE DETOX Single Drug Dip Card (OPI) SAFElife™ T-Dip Methamphetamine (MET/mAMP) Urine Test Panel Easy@Home® Multi-Drug Screen Test, EDOAP-1124 Easy@Home® Multi-Drug Screen Test, EDOAP-264 SAFElife™ T-Dip Methylenedioxymethamphetamine (MDMA) Urine Test Panel Mintegrity® Single-Panel Urine Test (Cannabinoids (THC)) SAFElife™ T-Dip Cocaine (COC150) Urine Test Panel Rx Easy@Home® Single Drug Screen Test Single Drug Urine Test Panel SAFElife™ T-Dip Methamphetamine (MET500/mAMP500) Urine Test Panel SAFElife™ T-Dip Cannabinoids (THC) Urine Test Panel Rx STATDIP® One Step Drug Test ONCORE DETOX Single Drug Dip Card (COC) ONCORE DETOX Multi-Drug Dip Card SAFElife™ T-Dip Single Drug Urine Test Panel iSCREEN™ Urine Test Dx Drug Screen Dip Card (Buprenorphine (BUP)) Easy@Home® Multi-Drug Screen Test, EDOAP-754 SAFElife™ T-Dip Amphetamine (AMP) Urine Test Panel Rx iSCREEN™ Urine Test Dx Drug Screen Dip Card (Oxycodone (OXY)) Easy@Home® Multi-Drug Screen Test, EDOAP-144 Easy@Home® Multi-Drug Screen Test, EDOAP-654 SAFElife™ T-Dip Amphetamine (AMP500) Urine Test Panel SAFElife™ T-Dip Phencyclidine (PCP) Urine Test Panel PRIME SCREEN® Single Panel Urine Test SAFElife™ T-Dip Multi-Drug Urine Test Panel Rx Easy@Home Multi-Drug Screen Test, EDOAP-4104 SAFElife™ T-Dip Multi-Drug Urine Test Panel SAFElife™ T-Dip Nortriptyline (TCA) Urine Test Panel Wondfo T-Dip Multi-Drug Urine Test Panel Rx PRIME SCREEN® Multi-Panel Urine Test ONCORE DETOX Single Drug Dip Card (THC) iSCREEN™ Urine Test Dx Drug Screen Dip Card (Methylenedioxymethamphetamine (MDMA)) Prime Screen® Multi-Panel Urine Test Wondfo T-Dip Multi-Drug Urine Test Panel SAFElife™ T-Dip Buprenorphine (BUP) Urine Test Panel Rx PRIME SCREEN® Single Panel Urine Test Oxazepam (BZO) Easy@Home Multi-Drug Screen Test, EDOAP-7125 SAFElife™ T-Dip Propoxyphene (PPX) Urine Test Panel SAFElife™ T-Dip Secobarbital (BAR) Urine Test Panel Easy@Home® Multi-Drug Screen Test, EDOAP-065 iSCREEN™ Urine Test Dx Drug Screen Dip Card (Methamphetamine (MET)) SAFElife™ T-Dip Amphetamine (AMP) Urine Test Panel SAFElife™ T-Dip Morphine (OPI) Urine Test Panel PRIME SCREEN® Single Panel Urine Test Cannabinoids (THC) PRIME SCREEN® Single Panel Urine Test Cocaine (COC) SAFElife™ T-Dip Morphine (MOP) Urine Test Panel Rx SAFElife™ T-Dip Methamphetamine (MET/mAMP) Urine Test Panel Rx SAFElife™ T-Dip Methadone (MTD) Urine Test Panel SAFElife™ T-Dip Methadone (MTD) Urine Test Panel Rx SAFElife™ T-Dip Oxycodone (OXY) Urine Test Panel Rx SAFElife™ T-Dip Propoxyphene (PPX) Urine Test Panel Rx SAFElife™ T-Dip Buprenorphine (BUP) Urine Test Panel iSCREEN™ URINE TEST DX DRUG SCREEN DIP CARD SAFElife™ T-Dip Oxycodone (OXY) Urine Test Panel Multi-Drug Screen Test SAFElife™ T-Dip Oxazepam (BZO) Urine Test Panel Single Drug Screen Test SAFElife™ T-Dip Phencyclidine (PCP) Urine Test Panel Rx Multi-Drug Urine Test Panel ONCORE DETOX Single Drug Dip Card (MET/mAMP)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198