BEUDAMED
    FDA Registration Active 🇨🇳 China

    DONGGUAN ZSR BIOMEDICAL TECHNOLOGY COMPANY LIMITED

    Reg #: 3016690337 · FEI: 3016690337 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

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    Registration Details

    Registration Name
    DONGGUAN ZSR BIOMEDICAL TECHNOLOGY COMPANY LIMITED
    Registration Number
    3016690337
    FEI Number
    3016690337
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Unit 448,Qingfeng Road,Taihu Village,Sanzhong Village Committee,Qingxi Town,Dongguan City,Guangdong Province., PEOPLE'S REPUBLIC OF CHINA
    City
    Dongguan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K243155

    Owner / Operator

    Firm Name
    Dongguan ZSR Biomedical Technology Company Limited
    Operator Number
    10092849
    Address
    Unit 448,Qingfeng Road,Taihu Village,Sanzhong Village Committee,Qingxi Town,Dongguan City,Guangdong Province., PEOPLE'S REPUBLIC OF CHINA
    City
    Dongguan
    State
    Guangdong
    Postal Code
    523651
    Country
    CN
    Correspondent
    Sharon Wen

    US Agent

    Business Name
    ZYPPEL LLC
    Contact Name
    Qihui Zhang
    Address
    1337 Massachusetts Ave Pmb 158
    City
    Arlington
    State
    MA
    ZIP
    02476
    Country
    US
    Email
    [email protected]
    Phone
    617 2991655

    Products

    Device Name Product Code
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Endoscopic Access Overtube, Gastroenterology-Urology FED

    Proprietary Names

    Electronic Endoscope Imaging Processor (ZSR-EOS10) Single-Use Digital Flexible Ureteroscope (F-URS: ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) Disposable Ureteral Guide Sheath

    Establishment Types

    Manufacture Medical Device