BEUDAMED
    FDA Registration Active 🇨🇳 China

    Healgen Accurate Home Multi-Drug Urine Test Cup

    Reg #: 3008517993 · FEI: 3008517993 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    ZHEJIANG ORIENT GENE BIOTECH
    Registration Number
    3008517993
    FEI Number
    3008517993
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3787 East Yangguang Avenue, Dipu Street, Anji
    City
    Huzhou Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K243365

    Owner / Operator

    Firm Name
    Zhejiang Orient Gene Biotech Co., Ltd
    Operator Number
    10033347
    Address
    679 East Yangguang Avenue
    City
    DIPU
    State
    Zhejiang
    Postal Code
    313300
    Country
    CN
    Correspondent
    JIANQIU FANG

    Products

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

    Proprietary Names

    Healgen Accurate Home Multi-Drug Urine Test Cup Healgen Accurate Multi-Drug Urine Drug Screen Cup

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)