BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    Harps Europe Manufacturing

    Reg #: 3007478974 · FEI: 3007478974 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Harps Europe Manufacturing
    Registration Number
    3007478974
    FEI Number
    3007478974
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    TRIESTER BUNDESSTRASSE 26
    City
    WIMPASSING NIEDEROSTERREICH
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K160781

    Owner / Operator

    Firm Name
    Harps Europe Manufacturing
    Operator Number
    8020005
    Address
    TRIESTER BUNDESSTRASSE 26, --
    City
    WIMPASSING NIEDEROSTERREICH
    State
    AT-NOTA
    Postal Code
    2632
    Country
    AT

    US Agent

    Business Name
    Mansour Consulting LLC
    Contact Name
    Jay Mansour
    Address
    845 Aronson Lake Court
    City
    Roswell
    State
    GA
    ZIP
    30075
    Country
    US
    Email
    [email protected]
    Phone
    678 9088180

    Products

    Device Name Product Code
    Surgeon'S Gloves KGO
    Medical Glove, Specialty LZC

    Proprietary Names

    Syntegra PreCision Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves Syntegra Green Sempermed Syntegra UV Henry Schein Criterion PI Dealmed Pivetal Latex Surgical

    Establishment Types

    Manufacture Medical Device