BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    ONEPASS MEDICAL LTD

    Reg #: 3043585886 · FEI: 3043585886 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ONEPASS MEDICAL LTD
    Registration Number
    3043585886
    FEI Number
    3043585886
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1st The Four street, Katzrin Industrial Park
    City
    Katzrin Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K251542

    Owner / Operator

    Firm Name
    OnePass Medical Ltd
    Operator Number
    10095214
    Address
    1st The Four street, Katzrin Industrial Park
    City
    Katzrin
    State
    Northern
    Postal Code
    1290000
    Country
    IL
    Correspondent
    Jacob Ben Arie

    US Agent

    Business Name
    MRC Global, LLC
    Contact Name
    Christine Scifert
    Address
    9160 Hwy 64, Suite 12
    City
    Lakeland
    State
    TN
    ZIP
    38002
    Country
    US
    Email
    [email protected]
    Phone
    901 8318053

    Products

    Device Name Product Code
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    Biopsy Needle FCG

    Proprietary Names

    InstaFAN

    Establishment Types

    Manufacture Medical Device