BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Curalife

    Reg #: 3026587627 · FEI: 3026587627 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    CURALIFE USA LTD
    Registration Number
    3026587627
    FEI Number
    3026587627
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    850 New Burton Road suite 201
    City
    Dover
    State
    DE
    ZIP
    19904
    Country
    US

    Regulatory Submissions

    510(k) Number
    K083628

    Owner / Operator

    Firm Name
    Curalife USA Ltd
    Operator Number
    10087349
    Address
    850 New Burton Road suite 201
    City
    Dover
    State
    DE
    Postal Code
    19904
    Country
    US
    Correspondent
    Ofer Yigdal

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Glucose Dehydrogenase, Glucose LFR
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    Curalife Glucome

    Establishment Types

    Repack or Relabel Medical Device