Sentec Ag

FDA Filings

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.

FDA Registration(s)
Registration Number3004149774
FEI Number3004149774
NameStephen Gorski
Owner & OperatorSENTEC AG
Contact AddressRINGSTRASSE 39 --
THERWIL CH-NOTA CH-4106 CH
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressS65W35739 Piper Rd
Eagle, WI 53119 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
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 22015-12-30
Stephen Gorski [SENTEC AG]
V-STATS PC Software including V-CareNeT2015-12-30
Stephen Gorski [SENTEC AG]
SenTec Digital Monitoring System2015-12-30
Stephen Gorski [SENTEC AG]
SA-MAR Staysite Adhesive Pad2015-12-30
Stephen Gorski [SENTEC AG]
OV-A/P/N OxiVenT Sensor2015-12-30
Stephen Gorski [SENTEC AG]
MAR-SF Multi-site Attachment Ring2015-12-30
Stephen Gorski [SENTEC AG]
MAR-MI Multi-site Attachment Ring2015-12-30
Stephen Gorski [SENTEC AG]
EC-MI Ear Clip2015-12-30
Stephen Gorski [SENTEC AG]
VS-A/P/N V-SignTM Sensor 22015-12-30
Stephen Gorski [SENTEC AG]
V-STATS PC Software including V-CareNeT2015-12-30
Stephen Gorski [SENTEC AG]
SenTec Digital Monitoring System2015-12-30
Stephen Gorski [SENTEC AG]
SA-MAR Staysite Adhesive Pad2015-12-30
Stephen Gorski [SENTEC AG]
OV-A/P/N OxiVenT Sensor2015-12-30
Stephen Gorski [SENTEC AG]
MAR-SF Multi-site Attachment Ring2015-12-30
Stephen Gorski [SENTEC AG]
MAR-MI Multi-site Attachment Ring2015-12-30
Stephen Gorski [SENTEC AG]
EC-MI Ear Clip2015-12-30
Stephen Gorski [SENTEC AG]
VS-A/P/N V-SignTM Sensor 22015-12-30
Stephen Gorski [SENTEC AG]
V-STATS PC Software including V-CareNeT2015-12-30
Stephen Gorski [SENTEC AG]
SenTec Digital Monitoring System2015-12-30
Stephen Gorski [SENTEC AG]
SA-MAR Staysite Adhesive Pad2015-12-30
Stephen Gorski [SENTEC AG]
OV-A/P/N OxiVenT Sensor2015-12-30
Stephen Gorski [SENTEC AG]
MAR-SF Multi-site Attachment Ring2015-12-30
Stephen Gorski [SENTEC AG]
MAR-MI Multi-site Attachment Ring2015-12-30
Stephen Gorski [SENTEC AG]
EC-MI Ear Clip2015-12-30
Stephen Gorski [SENTEC AG]
VS-A/P/N V-SignTM Sensor 22015-12-30
Stephen Gorski [SENTEC AG]
V-STATS PC Software including V-CareNeT2015-12-30
Stephen Gorski [SENTEC AG]
SenTec Digital Monitoring System2015-12-30
Stephen Gorski [SENTEC AG]
SA-MAR Staysite Adhesive Pad2015-12-30
Stephen Gorski [SENTEC AG]
OV-A/P/N OxiVenT Sensor2015-12-30
Stephen Gorski [SENTEC AG]
MAR-SF Multi-site Attachment Ring2015-12-30
Stephen Gorski [SENTEC AG]
MAR-MI Multi-site Attachment Ring2015-12-30
Stephen Gorski [SENTEC AG]
EC-MI Ear Clip2015-12-30
SENTEC AG
SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software Including V-CareNet2015-12-17
Stephen Gorski [SENTEC AG]
VS-A/P/N V-SignTM Sensor 22010-12-29
Stephen Gorski [SENTEC AG]
V-STATS PC Software including V- CareNeT2010-12-29
Stephen Gorski [SENTEC AG]
SDMS SenTec Digital Monitoring System2010-12-29
Stephen Gorski [SENTEC AG]
RSS Series SpO2 Soft Sensors2010-12-29
Stephen Gorski [SENTEC AG]
MAR-SF Multi-site Attachment Ring2010-12-29
Stephen Gorski [SENTEC AG]
MAR-MI Multi-site Attachment Ring2010-12-29
Stephen Gorski [SENTEC AG]
EC-MI Ear Clip2010-12-29
Stephen Gorski [SENTEC AG]
VS-A/P/N V-SignTM Sensor 22010-12-29
Stephen Gorski [SENTEC AG]
V-STATS PC Software including V- CareNeT2010-12-29
Stephen Gorski [SENTEC AG]
SDMS SenTec Digital Monitoring System2010-12-29
Stephen Gorski [SENTEC AG]
RSS Series SpO2 Soft Sensors2010-12-29
Stephen Gorski [SENTEC AG]
MAR-SF Multi-site Attachment Ring2010-12-29
Stephen Gorski [SENTEC AG]
MAR-MI Multi-site Attachment Ring2010-12-29
Stephen Gorski [SENTEC AG]
EC-MI Ear Clip2010-12-29
Stephen Gorski [SENTEC AG]
VS-A/P/N V-SignTM Sensor 22010-12-29
Stephen Gorski [SENTEC AG]
V-STATS PC Software including V- CareNeT2010-12-29
Stephen Gorski [SENTEC AG]
SDMS SenTec Digital Monitoring System2010-12-29
Stephen Gorski [SENTEC AG]
RSS Series SpO2 Soft Sensors2010-12-29
Stephen Gorski [SENTEC AG]
MAR-SF Multi-site Attachment Ring2010-12-29
Stephen Gorski [SENTEC AG]
MAR-MI Multi-site Attachment Ring2010-12-29
Stephen Gorski [SENTEC AG]
EC-MI Ear Clip2010-12-29
SENTEC AG
SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE2010-12-03
Stephen Gorski [SENTEC AG]
SenTec Digital Monitoring System2008-12-16
Stephen Gorski [SENTEC AG]
SenTec Digital Monitoring System2008-12-16
Stephen Gorski [SENTEC AG]
SenTec Digital Monitoring System2008-12-16
SENTEC AG
SENTEC DIGITAL MONITORING SYSTEM2007-09-12

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091858014Anvers,Belgium -> New York/Newark Area, Newark, New JerseySERVICE GAS6 PKG
2020060970361Anvers,Belgium -> Norfolk, VirginiaMEDICAL DEVICES1580 PKG

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