BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    iSert Preloaded IOL System (Model No. 251)

    Reg #: 3007125265 · FEI: 3007125265 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    21
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HOYA MEDICAL SINGAPORE PTE LTD
    Registration Number
    3007125265
    FEI Number
    3007125265
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10 Biopolis Road #04-01/06, Chromos
    City
    Singapore Central Singapore
    Country
    SG

    Regulatory Submissions

    PMA Number
    P080004

    Owner / Operator

    Firm Name
    HOYA MEDICAL SINGAPORE PTE LTD
    Operator Number
    10026402
    Address
    10 Biopolis Road #04-01/06, Chromos
    City
    Singapore
    State
    Central Singapore
    Postal Code
    138670
    Country
    SG
    Correspondent
    SVETLANA BYKANOVA

    US Agent

    Business Name
    Hoya Surgical Optics
    Contact Name
    Rekha Janarthanan
    Address
    110 Progress Ave., Suite 175
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 8420193

    Products

    Device Name Product Code
    Intraocular Lens HQL

    Proprietary Names

    iSert Preloaded IOL System (Model No. 251) iSert Preloaded IOL System (Model No. 250) iSert Preloaded IOL System (Model No. 230) IPure B1PC PreVue Y PreVue C IPure B3PC IPure B3PY iSymm IOL (Model FC-60AD) IPure B1PY ezSert 255E iSpheric IOL (Model YA-60BBR) ezSert 254E iSert Preloaded IOL System (Model PY-60AD) iSert 254 iSert 255 iSert Preloaded IOL System (Model PY-60R) iSpheric IOL (Model YA-60BB) iSymm IOL (Model FY-60AD) iSert Preloaded IOL System (Model PC-60AD) iSert Preloaded IOL System (Model No. 231)

    Establishment Types

    Manufacture Medical Device