BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ACCUCHECK

    Reg #: 3003366417 · FEI: 3003366417 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    LRE MEDICAL GMBH
    Registration Number
    3003366417
    FEI Number
    3003366417
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    HOFER STRASSE 5
    City
    NOERDLINGEN Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K051376

    Owner / Operator

    Firm Name
    LRE MEDICAL GMBH
    Operator Number
    9049285
    Address
    HOFER STRASSE 5, --
    City
    NOERDLINGEN
    State
    Bavaria
    Postal Code
    86720
    Country
    DE

    US Agent

    Business Name
    mdi Consultants, Inc.
    Contact Name
    Alan Schwartz
    Address
    55 Northern Blvd., Suite 200, Great Neck, NY 11021
    City
    Great Neck
    State
    NY
    ZIP
    11021
    Country
    US
    Email
    [email protected]
    Phone
    516 4829001

    Products

    Device Name Product Code
    System, Test, Blood Glucose, Over The Counter NBW
    Glucose Oxidase, Glucose CGA
    Enzymatic Esterase--Oxidase, Cholesterol CHH

    Proprietary Names

    ACCUCHECK UCHECK ACCUCHECK INSTAND PLUS DUAL TESTING

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)