BEUDAMED
    FDA Registration Active 🇨🇳 China

    SEPLOU (ZHUHAI) CO.,LTD.

    Reg #: 3035480112 · FEI: 3035480112 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    SEPLOU (ZHUHAI) CO.,LTD.
    Registration Number
    3035480112
    FEI Number
    3035480112
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5th Floor, Building 1, No. 8, Keji 10th Road, Tangjiawan Town, High-tech Zone
    City
    Zhuhai Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K243025

    Owner / Operator

    Firm Name
    SEPLOU (ZHUHAI) CO.,LTD.
    Operator Number
    10092239
    Address
    5th Floor, Building 1, No. 8, Keji 10th Road, Tangjiawan Town, High-tech Zone
    City
    Zhuhai
    State
    Guangdong
    Postal Code
    519085
    Country
    CN
    Correspondent
    Vince Zeng

    US Agent

    Business Name
    Dynasty Medical Consulting Inc.
    Contact Name
    Linda Chen
    Address
    302 Round Lake Dr
    City
    Rosenberg
    State
    TX
    ZIP
    77469
    Country
    US
    Email
    [email protected]
    Phone
    832 3809688

    Products

    Device Name Product Code
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS
    Toothbrush, Manual EFW
    Dilator, Urethral KOE
    Bottle, Collection, Vacuum KDQ

    Proprietary Names

    Ureteral Access Sheath Ureteral Access Sheath With Suction Collection Stone Retrieval Basket DIS8000 Image Processor Medical Video Endoscope URS3005, URS3006, URS3016, URS3005E, URS3006E, URS3016E Single-Use Grasping Forceps Single-Use Biopsy Forceps Urethral Dilator Stone Collection Bottle

    Establishment Types

    Manufacture Medical Device