BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    EC-MI Ear Clip

    Reg #: 3004149774 · FEI: 3004149774 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    SENTEC AG
    Registration Number
    3004149774
    FEI Number
    3004149774
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    RINGSTRASSE 39
    City
    THERWIL Basel-Landschaft
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K101690

    Owner / Operator

    Firm Name
    SENTEC AG
    Operator Number
    9064082
    Address
    RINGSTRASSE 39, --
    City
    THERWIL
    State
    Basel-Landschaft
    Postal Code
    CH-4106
    Country
    CH

    US Agent

    Business Name
    Imagenix, Inc.
    Contact Name
    Stephen Gorski
    Address
    S65W35739 Piper Road
    City
    Eagle
    State
    WI
    ZIP
    53119
    Country
    US
    Email
    [email protected]
    Phone
    414 7374596

    Products

    Device Name Product Code
    Monitor, Carbon-Dioxide, Cutaneous LKD
    Oximeter, Ear DPZ
    Oximeter DQA

    Proprietary Names

    EC-MI Ear Clip RSS Series SpO2 Soft Sensors V-STATS PC Software including V- CareNeT VS-A/P/N V-SignTM Sensor 2 SDMS SenTec Digital Monitoring System MAR-MI Multi-site Attachment Ring MAR-SF Multi-site Attachment Ring

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device