BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    HOYA MEDICAL SINGAPORE PTE LTD

    Reg #: 3007125265 · FEI: 3007125265 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HOYA MEDICAL SINGAPORE PTE LTD
    Registration Number
    3007125265
    FEI Number
    3007125265
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    10 Biopolis Road #04-01/06, Chromos
    City
    Singapore Central Singapore
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K081346
    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
    Folders And Injectors, Intraocular Lens (Iol) MSS

    Proprietary Names

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

    Establishment Types

    Manufacture Medical Device