BEUDAMED
    FDA Registration Active 🇨🇳 China

    Carl Zeiss Meditec (Suzhou) Co., Ltd.

    Reg #: 3032734659 · FEI: 3032734659 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    36
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Carl Zeiss Meditec (Suzhou) Co., Ltd.
    Registration Number
    3032734659
    FEI Number
    3032734659
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4F, No.26 Wu Sheng Road, SIP
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K171007

    Owner / Operator

    Firm Name
    Carl Zeiss Meditec AG (Jena)
    Operator Number
    9053564
    Address
    Goeschwitzer Strasse 51-52
    City
    Jena
    State
    Thuringia
    Postal Code
    07745
    Country
    DE
    Correspondent
    Carl ZEISS Meditec AG (Jena)

    US Agent

    Business Name
    Carl Zeiss Meditec USA Inc
    Contact Name
    Paul Swift
    Address
    5300 Central Parkway
    City
    Dublin
    State
    CA
    ZIP
    94568
    Country
    US
    Email
    [email protected]
    Phone
    817 9258507

    Products

    Device Name Product Code
    Laser, Fluorescence Caries Detection NBL
    Microscope, Operating & Accessories, Ac-Powered, Ophthalmic HRM
    Microscope, Surgical EPT
    Microscope, Surgical, General & Plastic Surgery FSO

    Proprietary Names

    Fluorescence mode S88 / OPMI Lumera T S8/OPMI VISU 200 S100 / OPMI pico i RESIGHT 500 (with acccessories) RESIGHT 700 (with accessories) S8 / OPMI Lumera T S7 / OPMI VISU 160 S81 / OPMI Lumera T S7 / OPMI Lumera S7 / OPMI VISU 140 OPMI Lumera 700 OPMI 1 FR pro ARTEVO 800 UC 3D Digital Upgrade Kit S8/OPMI VISU 160 S8/OPMI VISU 210 OPMI Lumera i S81/OPMI VISU 160 S88/OPMI VISU 160 S88/OPMI VISU 210 S81/OPMI VISU 210 ARTEVO 750/850 Single-use lenses for RESIGHT OPMI Lumera 300 EXTARO 300; Reusable Asepsis Caps OPMI PENTERO 800 and accessories S7 / OPMI PROergo and accessories S7 / OPMI Sensera and accessories S100 / OPMI pico and accessories BLUE 400 KINEVO 900 and accessories TIVATO 700 and accessories OPMI PENTERO 900 and accessories PENTERO 800 S KINEVO 900 S

    Establishment Types

    Manufacture Medical Device