BEUDAMED
    FDA Registration Active 🇧🇬 Bulgaria

    HOYA Corporation

    Reg #: 3033588952 · FEI: 3033588952 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HOYA Corporation
    Registration Number
    3033588952
    FEI Number
    3033588952
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Vasil Levski str. 179
    City
    Plovdiv
    Country
    BG

    Regulatory Submissions

    510(k) Number
    K171011

    Owner / Operator

    Firm Name
    HOYA Corporation PENTAX Division
    Operator Number
    8030235
    Address
    3 Paragon Drive
    City
    Montvale
    State
    NJ
    Postal Code
    07645
    Country
    US
    Correspondent
    Paresh Patel

    US Agent

    Business Name
    HOYA CORPORATION PENTAX DIVISION
    Contact Name
    Paresh Patel
    Address
    3 Paragon Dr
    City
    Montvale
    State
    NJ
    ZIP
    07645
    Country
    US
    Email
    [email protected]
    Phone
    201 5712300 ext. 2312

    Products

    Device Name Product Code
    Nasopharyngoscope (Flexible Or Rigid) EOB

    Proprietary Names

    VIDEO PROCESSOR (CP-1000) VIDEO NASOPHARYNGOLARYNGOSCOPE (VNL9-CP) Leakage test adapter (OE-B9)

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device