BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    OneTouch Ultra Plus Test Strips

    Reg #: 3008382007 · FEI: 3008382007 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    LIFESCAN EUROPE GMBH
    Registration Number
    3008382007
    FEI Number
    3008382007
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Dammstrasse 19
    City
    CH Zug
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K151611

    Owner / Operator

    Firm Name
    LifeScan Europe, GmbH
    Operator Number
    10032336
    Address
    Beechwood Park North
    City
    Inverness
    State
    Highland
    Postal Code
    IV2 3ED
    Country
    GB
    Correspondent
    Jenny Mackenzie

    US Agent

    Business Name
    LIFESCAN INC
    Contact Name
    Janice Thompson
    Address
    20 Valley Stream Parkway
    City
    Malvern
    State
    PA
    ZIP
    19355
    Country
    US
    Email
    [email protected]
    Phone
    484 8167226 ext. 10304

    Products

    Device Name Product Code
    System, Test, Blood Glucose, Over The Counter NBW
    Glucose Dehydrogenase, Glucose LFR

    Proprietary Names

    OneTouch Ultra Plus Test Strips OneTouch Ultra Plus Control Solution OneTouch Ultra Plus Flex Meter

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility