BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    LIFESCAN SCOTLAND LTD

    Reg #: 3001058982 · FEI: 3001058982 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    32
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    LIFESCAN SCOTLAND LTD
    Registration Number
    3001058982
    FEI Number
    3001058982
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    BEECHWOOD PARK NORTH
    City
    INVERNESS Highland
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K103553

    Owner / Operator

    Firm Name
    Lifescan Scotland Ltd.
    Operator Number
    9026104
    Address
    Beechwood Park North
    City
    Inverness
    State
    Highland
    Postal Code
    IV2 3ED
    Country
    GB
    Correspondent
    Polly - Middleton

    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 (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Glucose Oxidase, Glucose CGA
    Pump, Infusion, Insulin LZG
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK

    Proprietary Names

    OneTouch Verio Control Solution OneTouch Verio Test Strips OneTouch Verio IQ Blood Glucose Meter OneTouch Verio IQ Blood Glucose Monitoring System OneTouch Select Control Solutions OneTouch Ultra Control Solutions One Touch Ultra Mini Blood Glucose Monitoring System OneTouch Ultra Blue Test Strips OneTouch Ultra Mini Meter OneTouch Select Meter OneTouch Select Blood Glucose Monitoring System OneTouch Select Test Strip OneTouch Verio Blood Glucose Monitoring System OneTouch Verio Meter OneTouch Verio Reflect Blood Glucose Monitoring System OneTouch ultra Blue Test Strips OneTouch Ping Meter Remote OneTouch Ultra Plus Flex Blood Glucose Monitoring System OneTouch Ultra Plus Control Solution OneTouch Ultra Plus Test Strips OneTouch Ultra Plus Flex Meter One Touch Ultra 2 Blood Glucose Monitoring System One Touch Ultra 2 Meter OneTouch Delica Lancing Device and Lancets OneTouch Lancing Device OneTouch UltraSoft Lancing Device and Lancets OneTouch FinePoint Lancets OneTouch Suresoft Lancet OneTouch Delica Plus Lancing Device and Lancets OneTouch Delica Safety Lancing Device and Lancets OneTouch Verio Flex Meter OneTouch Verio Flex Blood Glucose Monitoring System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198