BEUDAMED
    FDA Registration Active 🇨🇳 China

    FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)

    Reg #: 3029968414 · FEI: 3029968414 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GUANGDONG OPTOMEDIC TECHNOLOGIES, INC.
    Registration Number
    3029968414
    FEI Number
    3029968414
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Suite 503, Building A, Golden Valley Intellicreation Community, No. 2 Yonganbei Street, Daxu, Guicheng,Nanhai
    City
    Foshan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K242513

    Owner / Operator

    Firm Name
    Guangdong OptoMedic Technologies, Inc.
    Operator Number
    10088815
    Address
    Suite 503, Building A, Golden Valley Intellicreation Community,, No. 2 Yonganbei Street, Daxu, Guicheng,Nanhai
    City
    Foshan
    State
    Guangdong
    Postal Code
    528200
    Country
    CN
    Correspondent
    Kaiyi Liao

    US Agent

    Business Name
    Shenzhen Joyantech Consulting Co., Ltd.
    Contact Name
    Thomas Tang
    Address
    25 Hopewell Drive Stony Brook
    City
    Stony Brook
    State
    NY
    ZIP
    11790
    Country
    US
    Email
    [email protected]
    Phone
    631 9014608

    Products

    Device Name Product Code
    System, X-Ray, Angiographic IZI
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) Endoscopic Fluorescence lmaging System 71-068-05 NIR-CA, 71-068-10 NIR-CA, 71-068-20 NIR-CA,71-182-30 NIR-CA Endoscopic Fluorescence lmaging System 71-182-30 NIR, 71-068-05 NIR, 71-068-10 NIR, 71-068-20 NIR

    Establishment Types

    Manufacture Medical Device