BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    Hoya-IS Injector System

    Reg #: 3007125265 · FEI: 3007125265 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    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

    510(k) Number
    K081346

    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
    Folders And Injectors, Intraocular Lens (Iol) MSS

    Proprietary Names

    Hoya-IS Injector System

    Establishment Types

    Manufacture Medical Device