BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    SINGLE USE DISTAL CAP - ED34-I10T (OE-A62)

    Reg #: 3003782610 · FEI: 3003782610 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HOYA Corporation PENTAX Lifecare Division
    Registration Number
    3003782610
    FEI Number
    3003782610
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    30-2 Okada, Aza-Shimomiyano, Tsukidate
    City
    KURIHARA-SHI Miyagi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K163614

    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
    Gurvinder Nanda

    US Agent

    Business Name
    HOYA CORPORATION PENTAX DIVISION
    Contact Name
    Gurvinder Nanda
    Address
    3 Paragon Drive
    City
    Montvale
    State
    NJ
    ZIP
    07645
    Country
    US
    Email
    [email protected]
    Phone
    201 5712318

    Products

    Device Name Product Code
    Duodenoscope And Accessories, Flexible/Rigid FDT

    Proprietary Names

    SINGLE USE DISTAL CAP - ED34-I10T (OE-A62) C.A.P. HD DUODENOSCOPE US (ED34-I10T-US)

    Establishment Types

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