BEUDAMED
    FDA Registration Active 🇨🇳 China

    CO-INNOVATION BIOTECH CO.,LTD.

    Reg #: 3010220539 · FEI: 3010220539 · Expires 2026
    View on FDA
    Products
    29
    Proprietary Names
    16
    Establishment Types
    2
    Classifications
    29

    Registration Details

    Registration Name
    CO-INNOVATION BIOTECH CO.,LTD.
    Registration Number
    3010220539
    FEI Number
    3010220539
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 9 Baihe 3 street, Economic and Technological Development East Zone,
    City
    Guangzhou Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K231904

    Owner / Operator

    Firm Name
    Co-Innovation Biotech Co.,Ltd.
    Operator Number
    10042828
    Address
    No. 9 Baihe 3 street,Economic and, Technological Development East Zone,
    City
    Guangzhou
    State
    Guangdong
    Postal Code
    510530
    Country
    CN
    Correspondent
    Hong Feng

    Products

    Device Name Product Code
    Enzyme Immunoassay, Opiates DJG
    Test, Cannabinoid, Over The Counter NFW
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Barbiturate, Over The Counter PTH
    Test, Methadone, Over The Counter PTG
    Test, Benzodiazepine, Over The Counter NFV
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Methamphetamine, Over The Counter NGG
    Test, Phencyclidine (Pcp), Over The Counter NGM
    Test, Amphetamine, Over The Counter NFT
    Test, Propoxyphene, Over The Counter QBF
    Test, Morphine, Over The Counter NGI
    Test, Opiates, Over The Counter NGL
    Radioimmunoassay, Luteinizing Hormone CEP
    Enzyme Immunoassay, Barbiturate DIS
    Enzyme Immunoassay, Phencyclidine LCM
    Enzyme Immunoassay, Benzodiazepine JXM
    Thin Layer Chromatography, Morphine DNK
    Thin Layer Chromatography, Methamphetamine DJC
    Enzyme Immunoassay, Propoxyphene JXN
    Enzyme Immunoassay, Amphetamine DKZ
    Gas Chromatography, Methamphetamine LAF
    Enzyme Immunoassay, Methadone DJR
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Enzyme Immunoassay, Cannabinoids LDJ
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Test, Follicle Stimulating Hormone (Fsh), Over The Counter NGA
    Test System, Nicotine, Cotinine, Metabolites MRS

    Proprietary Names

    Rapid Fentanyl (FYL) Test Strip ,Rapid Fentanyl (FYL) Test Dipcard U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold) CheckYo Ovulation Test Strip Areta Ovulation Test Strip Areta Ovulation Test Kit Co-innovation ACCU KNOW Urine Drug Test Cannabinoid (THC) Test System Easy@Home Marijuana Test Strip (THC 20),ESTH-215 Rapid Urine Fentanyl ( FYL ) Test Strip ,Rapid Urine Fentanyl ( FYL ) Test Dipcard CheckYo Pregnancy Test Midstream Areta Pregnancy Test Strip CheckYo Pregnancy&Ovulation Combo Test Kit CheckYo Pregnancy Test Strip FSH Menopause Test Rapid COT Test

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)