This page includes the latest FDA filings for Envitec Wismar G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 9617268 |
| FEI Number | 1000352675 |
| Name | Stephen Gorski |
| Owner & Operator | EnviteC-Wismar GmbH |
| Contact Address | Alter Holzhafen 19 Wismar DE-MV Mecklenburg-Vorpommern 23966 DE |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | S 65 W 35739 PIPER RD Eagle, WI 53119 US |
| Establishment Type |
|
Device Company | Device | Date |
|---|---|---|
| EnviteC-Wismar GmbH | Oxygen Sensor E1002573 | 2022-06-27 |
| EnviteC-Wismar GmbH | Disposable sensor 1002324 | 2021-11-10 |
| EnviteC-Wismar GmbH | Disposable Sensor 1002215 | 2021-11-10 |
| EnviteC-Wismar GmbH | MySign® S 1002197 | 2021-11-10 |
| EnviteC-Wismar GmbH | Disposable Sensor 1001834 | 2021-11-10 |
| EnviteC-Wismar GmbH | Disposable Sensor 08-00-0478 | 2021-11-10 |
| EnviteC-Wismar GmbH | Disposable Sensor 08-00-0333 | 2021-11-10 |
| EnviteC-Wismar GmbH | Disposable Sensor 08-00-0323 | 2021-11-10 |
| EnviteC-Wismar GmbH | Disposable Sensor 08-00-0127 | 2021-11-10 |
| EnviteC-Wismar GmbH | Disposable Sensor 08-00-0468 | 2021-11-10 |
| EnviteC-Wismar GmbH | Disposable Sensor 08-00-0131 | 2021-11-10 |
| EnviteC-Wismar GmbH | Disposable Sensor 08-00-0123 | 2021-11-10 |
| EnviteC-Wismar GmbH | Oxygen Sensor E1002857 | 2021-05-11 |
| EnviteC-Wismar GmbH | SoftTip® large 1002302 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® small 1002212 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® medium 1002211 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® large 1002210 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® small 1002203 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® small 1002202 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® medium 1002201 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® medium 1002200 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® large 1002199 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® large 1002198 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® small 1002140 | 2020-04-30 |
| EnviteC-Wismar GmbH | Y-Sensor 09-00-0216 | 2020-04-30 |
| EnviteC-Wismar GmbH | Y-Sensor 09-00-0213 | 2020-04-30 |
| EnviteC-Wismar GmbH | Y-Sensor 09-00-0144 | 2020-04-30 |
| EnviteC-Wismar GmbH | Y-Sensor 09-00-0124 | 2020-04-30 |
| EnviteC-Wismar GmbH | Y-Sensor 09-00-0123 | 2020-04-30 |
| EnviteC-Wismar GmbH | Y-Sensor 09-00-0120 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® medium 1001076 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® medium 06-00-1368 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip small 06-00-0814 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip large 06-00-0765 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® large 1000396 | 2020-04-30 |
| EnviteC-Wismar GmbH | Y-Sensor 09-00-0112 | 2020-04-30 |
| EnviteC-Wismar GmbH | Y-Sensor 09-00-0092 | 2020-04-30 |
| EnviteC-Wismar GmbH | Y-Sensor 09-00-0086 | 2020-04-30 |
| EnviteC-Wismar GmbH | Y-Sensor 09-00-0087 | 2020-04-30 |
| EnviteC-Wismar GmbH | Y-Sensor 09-00-0119 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® medium 06-00-1378 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® medium 06-00-1380 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® medium 06-00-1392 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® medium 06-00-1377 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® medium 06-00-1371 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® medium 06-00-1370 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® medium 06-00-1369 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® medium 06-00-1366 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® medium 06-00-1365 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® medium 06-00-1364 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® medium 06-00-1361 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip small 06-00-0815 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip small 06-00-0729 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip small 06-00-0822 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip small 06-00-0716 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip small 06-00-0583 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip small 06-00-0712 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip small 06-00-0724 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip small 06-00-0726 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip small 06-00-0591 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip large 06-00-0766 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip large 06-00-0727 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip large 06-00-0771 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip large 06-00-0715 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip large 06-00-0584 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip large 06-00-0709 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip large 06-00-0711 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip large 06-00-0723 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip large 06-00-0725 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® large 06-00-1070 | 2020-04-30 |
| EnviteC-Wismar GmbH | SoftTip® large 06-00-0115 | 2020-04-30 |
| EnviteC-Wismar GmbH | Oxygen Sensor 01-00-0097 | 2020-04-27 |
| EnviteC-Wismar GmbH | Oxygen Sensor 01-00-0068 | 2020-04-27 |
| EnviteC-Wismar GmbH | Oxygen Sensor 01-00-0021 | 2020-04-27 |
| EnviteC-Wismar GmbH | Oxygen Sensor 01-00-0047 | 2020-04-27 |
| EnviteC-Wismar GmbH | Oxygen Sensor 01-00-0014 | 2020-04-27 |
| EnviteC-Wismar GmbH | Oxygen Sensor 01-00-0098 | 2020-04-27 |
| EnviteC-Wismar GmbH | Oxygen Sensor 01-00-0058 | 2020-04-27 |
| EnviteC-Wismar GmbH | Oxygen Sensor 01-00-0091 | 2020-04-27 |
| EnviteC-Wismar GmbH | Oxygen Sensor 01-00-0053 | 2020-04-27 |
| EnviteC-Wismar GmbH | Oxygen Sensor 01-00-0049 | 2020-04-27 |
| EnviteC-Wismar GmbH | Oxygen Sensor 01-00-0090 | 2020-04-27 |
| EnviteC-Wismar GmbH | Oxygen Sensor 01-00-0016 | 2020-04-27 |
| EnviteC-Wismar GmbH | Oxygen Sensor 01-00-0015 | 2020-04-27 |
| EnviteC-Wismar GmbH | Oxygen Sensor E01-00-0020 | 2020-04-27 |
| EnviteC-Wismar GmbH | Oxygen Sensor 01-00-0019 | 2020-04-27 |
| EnviteC-Wismar GmbH | Oxygen Sensor 01-00-0013 | 2020-04-27 |
| EnviteC-Wismar GmbH | Oxygen Sensor 01-00-0114 | 2020-04-27 |
| EnviteC-Wismar GmbH | FingerClip 06-00-1080 | 2020-04-24 |
| EnviteC-Wismar GmbH | FingerClip 06-00-0264 | 2020-04-24 |
| EnviteC-Wismar GmbH | FingerClip 06-00-0246 | 2020-04-24 |
| EnviteC-Wismar GmbH | FingerClip 06-00-1268 | 2020-04-24 |
| EnviteC-Wismar GmbH | FingerClip 06-00-1074 | 2020-04-24 |
| EnviteC-Wismar GmbH | FingerClip 06-00-1075 | 2020-04-24 |
| EnviteC-Wismar GmbH | FingerClip 06-00-0216 | 2020-04-24 |
| EnviteC-Wismar GmbH | FingerClip 06-00-0925 | 2020-04-24 |
| EnviteC-Wismar GmbH | FingerClip 06-00-0200 | 2020-04-24 |
| EnviteC-Wismar GmbH | FingerClip 06-00-1066 | 2020-04-24 |
| EnviteC-Wismar GmbH | OxiPen® 1000159 | 2020-04-24 |
| EnviteC-Wismar GmbH | OxiPen® 1000155 | 2020-04-24 |
Stephen Gorski [EnviteC-Wismar GmbH] | MySign S Pulse Oximeter and Accessory SpO2 Sensors | 2019-05-23 |
Stephen Gorski [EnviteC-Wismar GmbH] | MySign PC Software | 2019-05-23 |
Stephen Gorski [EnviteC-Wismar GmbH] | MySign S Pulse Oximeter and Accessory SpO2 Sensors | 2019-05-23 |
Stephen Gorski [EnviteC-Wismar GmbH] | MySign PC Software | 2019-05-23 |
Stephen Gorski [EnviteC-Wismar GmbH] | MySign O Oxygen Measuring Device | 2019-05-23 |
Stephen Gorski [EnviteC-Wismar GmbH] | EnviteC Reusable SpO2 Sensors | 2019-05-23 |
Stephen Gorski [EnviteC-Wismar GmbH] | EnviteC Reusable SpO2 Sensors | 2019-05-23 |
Stephen Gorski [EnviteC-Wismar GmbH] | EnviteC Reusable SpO2 Sensors | 2019-05-23 |
Stephen Gorski [EnviteC-Wismar GmbH] | EnviteC Medical Oxygen Sensors | 2019-05-23 |
Stephen Gorski [EnviteC-Wismar GmbH] | EnviteC OxiPen Pulse Oximeter and Accessories | 2019-05-23 |
Stephen Gorski [EnviteC-Wismar GmbH] | EnviteC Reusable SoftTip SpO2 Sensors | 2019-05-23 |
Stephen Gorski [EnviteC-Wismar GmbH] | EnviteC Reusable Multi-site Y-Sensor | 2019-05-23 |
Stephen Gorski [EnviteC-Wismar GmbH] | MOX9 | 2019-05-23 |
Stephen Gorski [EnviteC-Wismar GmbH] | MOX6 | 2019-05-23 |
Stephen Gorski [EnviteC-Wismar GmbH] | MOX4 | 2019-05-23 |
Stephen Gorski [EnviteC-Wismar GmbH] | MOX3 | 2019-05-23 |
Stephen Gorski [EnviteC-Wismar GmbH] | MOX2 | 2019-05-23 |
Stephen Gorski [EnviteC-Wismar GmbH] | 6050-0004-110 | 2019-05-23 |
Stephen Gorski [EnviteC-Wismar GmbH] | AlcoQuant 6020 Plus | 2019-05-23 |
Stephen Gorski [EnviteC-Wismar GmbH] | Flow Sensor SpiroQuant | 2019-05-23 |
Stephen Gorski [EnviteC-Wismar GmbH] | Flow Sensor SpiroQuant H | 2019-05-23 |
Stephen Gorski [EnviteC-Wismar GmbH] | Flow Sensor SpiroQuant A+ | 2019-05-23 |
Stephen Gorski [EnviteC-Wismar GmbH] | Multicompatible EnviteC Reusable and Disposable SpO2 Sensors | 2019-05-22 |
ENVITEC-WISMAR GMBH | MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31 | 2014-05-02 |
ENVITEC-WISMAR GMBH | ENVITEC MYSIGN O OXYGEN MEASURING DEVICE | 2013-01-23 |
ENVITEC-WISMAR GMBH | ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN | 2011-02-22 |
ENVITEC-WISMAR GMBH | REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR | 2009-07-24 |
ENVITEC-WISMAR GMBH | ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 | 2008-11-25 |
ENVITEC-WISMAR GMBH | ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES | 2007-05-02 |
ENVITEC-WISMAR GMBH | ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS | 2006-07-17 |
ENVITEC-WISMAR GMBH | ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS | 2005-02-11 |
ENVITEC-WISMAR GMBH | MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED | 2000-03-29 |
| NCAGE Code | D3554 | ENVITEC-WISMAR GMBH |
| CAGE Code | D3554 | ENVITEC-WISMAR GMBH |