BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    SENTEC AG

    Reg #: 3004149774 · FEI: 3004149774 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    48
    Establishment Types
    3
    Classifications
    6

    Registration Details

    Registration Name
    SENTEC AG
    Registration Number
    3004149774
    FEI Number
    3004149774
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    RINGSTRASSE 39
    City
    THERWIL Basel-Landschaft
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K071672

    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
    Oximeter DQA
    Monitor, Carbon-Dioxide, Cutaneous LKD
    Oximeter, Ear DPZ
    Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia LPP
    Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia KLK
    Ventilatory Electrical Impedance Tomograph QEB

    Proprietary Names

    SenTec Digital Monitoring System RSS Series SpO2 Soft Sensors EC-MI Ear Clip VS-A/P/N V-SignTM Sensor 2 SDMS SenTec Digital Monitoring System V-STATS PC Software including V- CareNeT MAR-SF Multi-site Attachment Ring MAR-MI Multi-site Attachment Ring 103164 tCOM+ Patient Monitor 103149 Calibration Gas tCOM+ 103421 Sensor Adapter Cable (Long) tCOM+ 103420 Sensor Adapter Cable (Regular) tCOM+ 103422 Sensor Adapter Cable (Extra Long) tCOM+ 1ST272-100 LuMon™ Belt 19 1ST278-100 LuMon™ Belt 47 1ST274-100 LuMon™ Belt 26 1ST282-100 LuMon™ Belt 80 1ST283-100 LuMon™ Belt 92 1ST275-100 LuMon™ Belt 30 2ST200-100 LuMon™ Monitor 1ST276-100 LuMon™ Belt 35 1ST277-100 LuMon™ Belt 40 1ST120-100 LuMon™ Connector 2 103583 LuMon™ Contact Gel 1ST273-100 LuMon™ Belt 22 1ST285-100 LuMon™ Belt 116 1ST284-100 LuMon™ Belt 104 V-STATS PC Software including V-CareNeT SA-MAR Staysite Adhesive Pad OV-A/P/N OxiVenT Sensor MR Membrane Changer GEL-04 Contact Gel PSG-A to PSG-X PSG Adapter Cables PAK-MI Patient Application Kit for mature/intact skin GEL-SD Single Dose Contact Gel GAS-0812 Service Gas MARe-MI Multi-Site Attachment Ring Easy PAK-EC Patient Application Kit with Ear Clip for mature/intact skin PAK-SF Patient Application Kit for sensitive/fragile skin RFT100VA-V1 Isolation Transformer AC-250 Adapter Cable MC-I Membrane Changer Insert SDM_WPC Sentec Water Protection Cover AC-150 Adapter Cable MARe-SF Multi-Site Attachment Ring Easy MC Membrane Changer AC-750 Adapter Cable 103520 Non-Adhesive Wrap

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility