BEUDAMED
    FDA Registration Active 🇨🇳 China

    HANGZHOU GENESIS BIODETECTION & BIOCONTROL CO., LTD.

    Reg #: 3017231634 · FEI: 3017231634 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    HANGZHOU GENESIS BIODETECTION & BIOCONTROL CO., LTD.
    Registration Number
    3017231634
    FEI Number
    3017231634
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    #139 10th Street (East), Hangzhou Economic and Technology Development Zone
    City
    Hangzhou Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K231027

    Owner / Operator

    Firm Name
    Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.
    Operator Number
    10078538
    Address
    #139 10th Street (East), Hangzhou Economic and Technology Development Zone
    City
    Hangzhou
    State
    Zhejiang
    Postal Code
    310018
    Country
    CN
    Correspondent
    Reuben Weng

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Reagent, Occult Blood KHE
    Container, Specimen, Sterile FMH
    Applicator, Absorbent Tipped, Sterile KXG
    Culture Media, Non-Selective And Non-Differential JSG
    Culture Media, Non-Propagating Transport JSM

    Proprietary Names

    OC-Light S FIT KaiBiLi Saliva Collection Kit Disposable sampling swab Genesis Sampling Swab KaiBiLi Extended ViralTrans Saline KaiBiLi Extended ViralTrans PBS Vaginal Swab Kit KaiBiLi Extended ViralTrans

    Establishment Types

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