BEUDAMED
    FDA Registration Active 🇨🇳 China

    Healgen® Accurate Fentanyl Rapid Test Strip (Urine)

    Reg #: 3008517993 · FEI: 3008517993 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    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
    K240949

    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, Opiates, Over The Counter NGL

    Proprietary Names

    Healgen® Accurate Fentanyl Rapid Test Strip (Urine) Healgen® Accurate Rapid Fentanyl Test Cassette (Urine) Healgen® Accurate Fentanyl Rapid Test Cassette (Urine) Healgen® Accurate Rapid Fentanyl Test Strip (Urine) Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine) Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)