BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO., LTD.

    Reg #: 3005755367 · FEI: 3005755367 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    18
    Establishment Types
    2
    Classifications
    13

    Registration Details

    Registration Name
    SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO., LTD.
    Registration Number
    3005755367
    FEI Number
    3005755367
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.7, MingPu Phase II, No.3279, SanLu Road, MinHang District, Shanghai, China
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K142263

    Owner / Operator

    Firm Name
    Shanghai MediWorks Precision Instruments Co., Ltd.
    Operator Number
    10031036
    Address
    No.7, MingPu Phase II, No.3279, SanLu Road, MinHang District, Shanghai, China
    City
    Shanghai
    State
    CN-SH
    Postal Code
    201100
    Country
    CN
    Correspondent
    weida Zhan

    Products

    Device Name Product Code
    Biomicroscope, Slit-Lamp, Ac-Powered, Exempt PUE
    Tonometer, Manual HKY
    Table, Instrument, Powered, Ophthalmic HRJ
    Camera, Ophthalmic, Ac-Powered HKI
    Biomicroscope, Slit-Lamp, Ac-Powered HJO
    Medical Device Data System OUG
    Microscope, Operating & Accessories, Ac-Powered, Ophthalmic HRM
    Refractometer, Ophthalmic HKO
    Lens, Condensing, Diagnostic HJL
    Camera, Ophthalmic, General-Use PJZ
    Microscope, Surgical, General & Plastic Surgery FSO
    Topographer, Corneal, Ac-Powered MMQ
    Chart, Visual Acuity HOX

    Proprietary Names

    Portable Slit Lamps S150 Applanation Tonometers Instrument table Resolve Fundus Camera Slit Lamp Microscopes Digital Camera Module Kit DM390,DS650 Surgical Microscopes SM610 SM620 SM622C SM629F SM626M SM628S SM625D SM623D SM621 SM660 Vision screeners V100 V101 V102 Ophthalmic RefractometerV100 V101 V102 Retina Lens 20D 78D 90D Hand-held Fundus Camera FC160 FC161 Automatic Fundus Camera FC162 StereOptic Inverter600A;Fundus Viewing System600B Three-dimensional Analysis Systems for the Anterior Eye Segment Scansys TA517 Slitlamp biomicroscope Scansys TA517 Anterior segment analyzer Scansys TA517 Corneal Topographer DEA520 Vision Charts C901

    Establishment Types

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