BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Flexible Intubation Video Endoscope – Sterile (FIVE-S)

    Reg #: 3008439484 · FEI: 3008439484 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KUNSTSTOFF HELMBRECHTS AG
    Registration Number
    3008439484
    FEI Number
    3008439484
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Pressecker Str. 39
    City
    Helmbrechts Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K212656

    Owner / Operator

    Firm Name
    Kunststoff Helmbrechts AG
    Operator Number
    10059824
    Address
    Pressecker Str. 39
    City
    Helmbrechts
    State
    DE-NOTA
    Postal Code
    95233
    Country
    DE

    US Agent

    Business Name
    confinis USA Inc.
    Contact Name
    Alfred Lerch
    Address
    600 Park Offices Drive Suite 300, Unit #50
    City
    Durham
    State
    NC
    ZIP
    27709
    Country
    US
    Email
    [email protected]
    Phone
    910 2289391

    Products

    Device Name Product Code
    Bronchoscope (Flexible Or Rigid) EOQ

    Proprietary Names

    Flexible Intubation Video Endoscope – Sterile (FIVE-S)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)