BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    LIFESCAN EUROPE GMBH

    Reg #: 3008382007 · FEI: 3008382007 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    20
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    LIFESCAN EUROPE GMBH
    Registration Number
    3008382007
    FEI Number
    3008382007
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Dammstrasse 19
    City
    CH Zug
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K131363

    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
    Jennifer Mackenzie

    US Agent

    Business Name
    LIFESCAN US LLC
    Contact Name
    Amber Wingler
    Address
    75 Valley Stream Pkwy
    City
    Malvern
    State
    PA
    ZIP
    19355
    Country
    US
    Email
    [email protected]
    Phone
    484 3207594

    Products

    Device Name Product Code
    Glucose Dehydrogenase, Glucose LFR
    System, Test, Blood Glucose, Over The Counter NBW
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK

    Proprietary Names

    OneTouch Verio Blood Glucose Monitoring System OneTouch Verio Test Strips OneTouch Verio Control Solution OneTouch Verio Meter OneTouch SureSoft Lancet OneTouch UltraSoft Lancing Device and Lancets OneTouch FinePoint Lancets OneTouch Lancing Device OneTouch Delica Lancing Device and Lancets OneTouch Delica Plus Lancing Device and Lancets OneTouch Delica Safety Lancing Device and Lancets OneTouch Verio Reflect Blood Glucose Monitoring System OneTouch Solutions OneTouch Ultra Plus Control Solution OneTouch Ultra Plus Test Strips OneTouch Ultra Plus Flex Meter OneTouch Verio IQ Blood Glucose Monitoring System OneTouch Verio Control Solutions OneTouch Verio IQ Meter OneTouch Verio Flex Meter

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility