BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ANNE Pediatric

    Reg #: 3015529350 · FEI: 3015529350 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    SIBEL HEALTH INC.
    Registration Number
    3015529350
    FEI Number
    3015529350
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2017 N Mendell Street, Suite 2SE
    City
    Chicago
    State
    IL
    ZIP
    60614
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221530

    Owner / Operator

    Firm Name
    Sibel Inc.
    Operator Number
    10060887
    Address
    2017 N Mendell Street, Suite 2SE
    City
    Chicago
    State
    IL
    Postal Code
    60614
    Country
    US
    Correspondent
    Kevin Dwyer

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG

    Proprietary Names

    ANNE Pediatric

    Establishment Types

    Manufacture Medical Device