This page includes the latest FDA filings for Sentec Ag. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3004149774 |
| FEI Number | 3004149774 |
| Name | Stephen Gorski |
| Owner & Operator | SENTEC AG |
| Contact Address | RINGSTRASSE 39 -- THERWIL CH-NOTA CH-4106 CH |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | S65W35739 Piper Rd Eagle, WI 53119 US |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| SenTec AG | 1ST285-100 LuMon™ Belt Size 116 | 2025-09-16 |
| SenTec AG | 1ST284-100 LuMon™ Belt Size 104 | 2025-09-16 |
| SenTec AG | 1ST283-100 LuMon™ Belt Size 92 | 2025-09-16 |
| SenTec AG | 1ST282-100 LuMon™ Belt Size 80 | 2025-09-16 |
| SenTec AG | 1ST278-100 LuMon™ Belt Size 47 | 2025-09-16 |
| SenTec AG | 1ST277-100 LuMon™ Belt Size 40 | 2025-09-16 |
| SenTec AG | 1ST276-100 LuMon™ Belt Size 35 | 2025-09-16 |
| SenTec AG | 1ST275-100 LuMon™ Belt Size 30 | 2025-09-16 |
| SenTec AG | 1ST274-100 LuMon™ Belt Size 26 | 2025-09-16 |
| SenTec AG | 1ST273-100 LuMon™ Belt Size 22 | 2025-09-16 |
| SenTec AG | 1ST272-100 LuMon™ Belt Size 19 | 2025-09-16 |
| SenTec AG | 1ST120-100 LuMon™ Connector 2.0 | 2025-09-16 |
| SenTec AG | 103583 LuMon™ Contact Gel Kit | 2025-09-16 |
| SenTec AG | 103422 Sensor Adapter Cable (Extra Long) | 2024-07-15 |
| SenTec AG | 103421 Sensor Adapter Cable (Long) | 2024-07-15 |
| SenTec AG | 103420 Sensor Adapter Cable (Regular) | 2024-07-15 |
| SenTec AG | 103164 tCOM+ | 2024-07-15 |
| SenTec AG | 103149 Calibration Gas | 2024-07-15 |
| SenTec AG | Non-Adhesive Wrap | 2023-07-31 |
| SenTec AG | Patient Application Kit for sensitive/fragile skin | 2021-10-04 |
| SenTec AG | Patient Application Kit for mature intact skin | 2021-10-04 |
| SenTec AG | Patient Application Kit with Ear Clip for mature/intact skin | 2021-10-04 |
| SenTec AG | SDM Water Protection Cover | 2021-09-02 |
| SenTec AG | Isolation Transformer 100-120V | 2021-05-13 |
| SenTec AG | Membrane Changer (single-use) / single unit | 2021-03-08 |
| SenTec AG | Ear Clip easy | 2020-04-08 |
| SenTec AG | Membrane Changer (reloadable) / single unit | 2019-11-07 |
| SenTec AG | Multi-Site Attachment Ring for mature/intact skin | 2019-04-02 |
| SenTec AG | Contact Gel 2ml | 2019-03-18 |
| SenTec AG | Contact Gel | 2019-03-13 |
| SenTec AG | Multi-Site Attachment Ring for fragile/sensitive s | 2019-03-01 |
| SenTec AG | PSG Cable P | 2018-12-13 |
| SenTec AG | PSG Cable N | 2018-12-13 |
| SenTec AG | PSG Cable M | 2018-12-13 |
| SenTec AG | PSG Cable L | 2018-12-13 |
| SenTec AG | PSG Cable K | 2018-12-13 |
| SenTec AG | PSG Cable J | 2018-12-13 |
| SenTec AG | PSG Cable H | 2018-12-13 |
| SenTec AG | PSG Cable G | 2018-12-13 |
| SenTec AG | PSG Cable F | 2018-12-13 |
| SenTec AG | PSG Cable E | 2018-12-13 |
| SenTec AG | PSG Cable D | 2018-12-13 |
| SenTec AG | PSG Cable C | 2018-12-13 |
| SenTec AG | PSG Cable B | 2018-12-13 |
| SenTec AG | PSG Cable A | 2018-12-13 |
| SenTec AG | PSG-X | 2018-12-13 |
| SenTec AG | V-STATS™ Installation CD | 2018-07-06 |
| SenTec AG | SenTec Digital Monitor (with activated PO2 channel | 2018-07-06 |
| SenTec AG | OxiVenT™ Sensor | 2018-07-06 |
| SenTec AG | Staysite Adhesive | 2018-07-06 |
| SenTec AG | V-Sign™ Sensor 2 | 2018-07-06 |
| SenTec AG | Membrane Changer Inserts | 2018-07-06 |
| SenTec AG | Membrane Changer Set | 2018-07-06 |
| SenTec AG | Neonatal Starter Set (without Service Gas) | 2018-07-06 |
| SenTec AG | Neonatal Starter Set | 2018-07-06 |
| SenTec AG | Standard Starter Set (without Service Gas) | 2018-07-06 |
| SenTec AG | Multi-Site Attachment Ring for fragile/sensitive s | 2018-07-06 |
| SenTec AG | Multi-Site Attachment Ring for mature/intact skin | 2018-07-06 |
| SenTec AG | Digital Sensor Adapter Cable, 750 cm | 2018-07-06 |
| SenTec AG | Digital Sensor Adapter Cable, 250 cm | 2018-07-06 |
| SenTec AG | Contact Gel | 2018-07-06 |
| SenTec AG | Service gas | 2018-07-06 |
| SenTec AG | Ear Clip | 2018-07-06 |
| SenTec AG | Digital Sensor Adapter Cable, 150 cm | 2018-07-06 |
| SenTec AG | SenTec Digital Monitor (without activated PO2 chan | 2018-07-06 |
| SenTec AG | Standard Starter Set | 2018-03-29 |
Stephen Gorski [SENTEC AG] | VS-A/P/N V-SignTM Sensor 2 | 2015-12-30 |
Stephen Gorski [SENTEC AG] | V-STATS PC Software including V-CareNeT | 2015-12-30 |
Stephen Gorski [SENTEC AG] | SenTec Digital Monitoring System | 2015-12-30 |
Stephen Gorski [SENTEC AG] | SA-MAR Staysite Adhesive Pad | 2015-12-30 |
Stephen Gorski [SENTEC AG] | OV-A/P/N OxiVenT Sensor | 2015-12-30 |
Stephen Gorski [SENTEC AG] | MAR-SF Multi-site Attachment Ring | 2015-12-30 |
Stephen Gorski [SENTEC AG] | MAR-MI Multi-site Attachment Ring | 2015-12-30 |
Stephen Gorski [SENTEC AG] | EC-MI Ear Clip | 2015-12-30 |
Stephen Gorski [SENTEC AG] | VS-A/P/N V-SignTM Sensor 2 | 2015-12-30 |
Stephen Gorski [SENTEC AG] | V-STATS PC Software including V-CareNeT | 2015-12-30 |
Stephen Gorski [SENTEC AG] | SenTec Digital Monitoring System | 2015-12-30 |
Stephen Gorski [SENTEC AG] | SA-MAR Staysite Adhesive Pad | 2015-12-30 |
Stephen Gorski [SENTEC AG] | OV-A/P/N OxiVenT Sensor | 2015-12-30 |
Stephen Gorski [SENTEC AG] | MAR-SF Multi-site Attachment Ring | 2015-12-30 |
Stephen Gorski [SENTEC AG] | MAR-MI Multi-site Attachment Ring | 2015-12-30 |
Stephen Gorski [SENTEC AG] | EC-MI Ear Clip | 2015-12-30 |
Stephen Gorski [SENTEC AG] | VS-A/P/N V-SignTM Sensor 2 | 2015-12-30 |
Stephen Gorski [SENTEC AG] | V-STATS PC Software including V-CareNeT | 2015-12-30 |
Stephen Gorski [SENTEC AG] | SenTec Digital Monitoring System | 2015-12-30 |
Stephen Gorski [SENTEC AG] | SA-MAR Staysite Adhesive Pad | 2015-12-30 |
Stephen Gorski [SENTEC AG] | OV-A/P/N OxiVenT Sensor | 2015-12-30 |
Stephen Gorski [SENTEC AG] | MAR-SF Multi-site Attachment Ring | 2015-12-30 |
Stephen Gorski [SENTEC AG] | MAR-MI Multi-site Attachment Ring | 2015-12-30 |
Stephen Gorski [SENTEC AG] | EC-MI Ear Clip | 2015-12-30 |
Stephen Gorski [SENTEC AG] | VS-A/P/N V-SignTM Sensor 2 | 2015-12-30 |
Stephen Gorski [SENTEC AG] | V-STATS PC Software including V-CareNeT | 2015-12-30 |
Stephen Gorski [SENTEC AG] | SenTec Digital Monitoring System | 2015-12-30 |
Stephen Gorski [SENTEC AG] | SA-MAR Staysite Adhesive Pad | 2015-12-30 |
Stephen Gorski [SENTEC AG] | OV-A/P/N OxiVenT Sensor | 2015-12-30 |
Stephen Gorski [SENTEC AG] | MAR-SF Multi-site Attachment Ring | 2015-12-30 |
Stephen Gorski [SENTEC AG] | MAR-MI Multi-site Attachment Ring | 2015-12-30 |
Stephen Gorski [SENTEC AG] | EC-MI Ear Clip | 2015-12-30 |
SENTEC AG | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software Including V-CareNet | 2015-12-17 |
Stephen Gorski [SENTEC AG] | VS-A/P/N V-SignTM Sensor 2 | 2010-12-29 |
Stephen Gorski [SENTEC AG] | V-STATS PC Software including V- CareNeT | 2010-12-29 |
Stephen Gorski [SENTEC AG] | SDMS SenTec Digital Monitoring System | 2010-12-29 |
Stephen Gorski [SENTEC AG] | RSS Series SpO2 Soft Sensors | 2010-12-29 |
Stephen Gorski [SENTEC AG] | MAR-SF Multi-site Attachment Ring | 2010-12-29 |
Stephen Gorski [SENTEC AG] | MAR-MI Multi-site Attachment Ring | 2010-12-29 |
Stephen Gorski [SENTEC AG] | EC-MI Ear Clip | 2010-12-29 |
Stephen Gorski [SENTEC AG] | VS-A/P/N V-SignTM Sensor 2 | 2010-12-29 |
Stephen Gorski [SENTEC AG] | V-STATS PC Software including V- CareNeT | 2010-12-29 |
Stephen Gorski [SENTEC AG] | SDMS SenTec Digital Monitoring System | 2010-12-29 |
Stephen Gorski [SENTEC AG] | RSS Series SpO2 Soft Sensors | 2010-12-29 |
Stephen Gorski [SENTEC AG] | MAR-SF Multi-site Attachment Ring | 2010-12-29 |
Stephen Gorski [SENTEC AG] | MAR-MI Multi-site Attachment Ring | 2010-12-29 |
Stephen Gorski [SENTEC AG] | EC-MI Ear Clip | 2010-12-29 |
Stephen Gorski [SENTEC AG] | VS-A/P/N V-SignTM Sensor 2 | 2010-12-29 |
Stephen Gorski [SENTEC AG] | V-STATS PC Software including V- CareNeT | 2010-12-29 |
Stephen Gorski [SENTEC AG] | SDMS SenTec Digital Monitoring System | 2010-12-29 |
Stephen Gorski [SENTEC AG] | RSS Series SpO2 Soft Sensors | 2010-12-29 |
Stephen Gorski [SENTEC AG] | MAR-SF Multi-site Attachment Ring | 2010-12-29 |
Stephen Gorski [SENTEC AG] | MAR-MI Multi-site Attachment Ring | 2010-12-29 |
Stephen Gorski [SENTEC AG] | EC-MI Ear Clip | 2010-12-29 |
SENTEC AG | SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE | 2010-12-03 |
Stephen Gorski [SENTEC AG] | SenTec Digital Monitoring System | 2008-12-16 |
Stephen Gorski [SENTEC AG] | SenTec Digital Monitoring System | 2008-12-16 |
Stephen Gorski [SENTEC AG] | SenTec Digital Monitoring System | 2008-12-16 |
SENTEC AG | SENTEC DIGITAL MONITORING SYSTEM | 2007-09-12 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020091858014 | Anvers,Belgium -> New York/Newark Area, Newark, New Jersey | SERVICE GAS | 6 PKG |
| 2020060970361 | Anvers,Belgium -> Norfolk, Virginia | MEDICAL DEVICES | 1580 PKG |