BEUDAMED
    FDA Registration Active 🇨🇳 China

    Suzhou Acuvu Medical Technology Co., Ltd.

    Reg #: 3021610866 · FEI: 3021610866 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    Suzhou Acuvu Medical Technology Co., Ltd.
    Registration Number
    3021610866
    FEI Number
    3021610866
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    B1-212, Bio-Nano Park, 218 Xinghu St. Suzhou Industrial Park
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K254050

    Owner / Operator

    Firm Name
    Process Control Services
    Operator Number
    10083910
    Address
    5 Oak Forest Court
    City
    Portola Valley
    State
    CA
    Postal Code
    94028
    Country
    US
    Correspondent
    Sam Mostafavi

    US Agent

    Business Name
    Process Control Services
    Contact Name
    Sam Mostafavi
    Address
    318 Bluefish Court
    City
    Foster City
    State
    CA
    ZIP
    94404
    Country
    US
    Email
    [email protected]
    Phone
    650 6706972

    Products

    Device Name Product Code
    Forceps HTD
    Scissors, General, Surgical LRW
    Hysteroscope (And Accessories) HIH
    Hysteroscope Accessories NWW

    Proprietary Names

    Disposable Hysteroscope accessory Disposable Hysteroscope System Manual Tissue Removal Device Manual Tissue Removal HTx Disposable Hysteroscope System eStar - reusable surgical instruments Hysteroscope accessories

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device