BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Topcon Yamagata Co., LTD

    Reg #: 3008729548 · FEI: 3008729548 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    75
    Establishment Types
    1
    Classifications
    14

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    Registration Details

    Registration Name
    Topcon Yamagata Co., LTD
    Registration Number
    3008729548
    FEI Number
    3008729548
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    547 aza Ishida Oaza Urushiyama Yamagata-SHI
    City
    Yamagata-KEN
    Country
    JP

    Owner / Operator

    Firm Name
    Topcon Healthcare, Inc.
    Operator Number
    9031569
    Address
    111 Bauer Drive
    City
    Oakland
    State
    NJ
    Postal Code
    07436
    Country
    US

    US Agent

    Business Name
    Topcon Healthcare, Inc.
    Contact Name
    Susan Quick
    Address
    111 Bauer Drive
    City
    Oakland
    State
    NJ
    ZIP
    07436
    Country
    US
    Email
    [email protected]
    Phone
    216 7805532

    Products

    Device Name Product Code
    Camera, Ophthalmic, Ac-Powered HKI
    Tomography, Optical Coherence OBO
    Microscope, Specular NQE
    System, Image Management, Ophthalmic NFJ
    Tonometer, Ac-Powered HKX
    Device, Analysis, Anterior Segment MXK
    Instrument, Measuring, Lens, Ac-Powered HLM
    Refractor, Manual, Non-Powered, Including Phoropter HKN
    Chart, Visual Acuity HOX
    Projector, Ophthalmic HOS
    Microscope, Operating & Accessories, Ac-Powered, Ophthalmic HRM
    Biomicroscope, Slit-Lamp, Ac-Powered HJO
    Instrument, Measuring, Corneal Radius HJB
    Refractometer, Ophthalmic HKO

    Proprietary Names

    3D OCT-1(type: Maestro2) DRI OCT Triton Plus 3D OCT-2000 FA DRI OCT-1 Model Triton Plus 3D OCT-2000 (50k) DRI OCT Triton 3D OCT-2000 FA plus 3D OCT-1 Maestro DRI OCT-1 Model Triton 3D OCT-1 (Type:Maestro2) DRI OCT Triton2 SP-3000P TRC-50DX IMAGEnet6 TRK-3 OMNIA LM-8; LM-8E; CL-200; EZ-200 CL-300 IMAGEnet 6 TRC-NW400 CT-800 CT-1P CT-1 TRK-1P TRK-2P CT-800A VT-10 CV-5000 SS-3 MC-4S MIRROR CHART MC-5S PC-50S ACP-8 ACP-8R NW500 OMS-90 OMS-710 OMS-800 SP-1P SL-D301 3D OCT-2000 3D OCT-1000 SL-2G IMAGEnet R4 TRC-NW8F plus CT-80 TRC-NW300 IMAGEnet 7 OM-4 TRC-NW7SF MARK II TRC-NW8 3D OPTICAL COHERENCE TOMOGRAPHY (3D OCT-1(type: Maestro2)) IMAGEnet6 Ophthalmic Data System SL-D701 3D OCT-1000 MARK II DRI OCT Triton (plus) TRC-NW8F SL-D2 SL-D4 SL-D7 SL-3G SL-D8Z SL-1E SL-D4 (Type:LED) IMAGEnet 5 KR-800S KR-1W KR-800A RM-800 KR-8000PA KR-800PA KR-8900 KR-1 Chronos RM-8900 KR-800

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)