BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SIGNOS, INC.

    Reg #: 3041000794 · FEI: 3041000794 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    1

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    Registration Details

    Registration Name
    SIGNOS, INC.
    Registration Number
    3041000794
    FEI Number
    3041000794
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    30011 Ivy Glenn Dr Ste 107
    City
    Laguna Niguel
    State
    CA
    ZIP
    92677
    Country
    US

    Regulatory Submissions

    510(k) Number
    K250106

    Owner / Operator

    Firm Name
    Signos, Inc.
    Operator Number
    10094001
    Address
    30011 Ivy Glenn, Suite 107
    City
    Laguna Niguel
    State
    CA
    Postal Code
    92677
    Country
    US
    Correspondent
    Trevor Denbo

    Products

    Device Name Product Code
    Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter SAF

    Proprietary Names

    Signos Signos Glucose Management System Signos GMS

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device