Envitec-Wismar GmbH
Country not established
- Devices
- 9
What Envitec-Wismar GmbH makes
Envitec-Wismar GmbH manufactures reusable and disposable pulse oximetry sensors, including finger clip, ear, and soft-tip designs for adult and pediatric use. Their products are compatible with multiple medical device brands, such as Philips and Nihon-Kohden, and include standalone pulse oximeters like the OXIPEN and MYSIGN S series. Accessories like finger clips and optional software for data management are also part of their portfolio.
The company’s devices fall under Class II regulatory classification in the US, with submissions recorded in the FDA 510(k) registry. Their products are listed under the US jurisdiction, and the company is based in the United States.
Catalogue
Envitec Reusable Multi-Site Y SPO2 Sensors Ref K043463
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Envitec Reusable SPO2 Sensors Type Nihon-Kohden Ref K102270
Regimes: 510(k) Registry: 510(k)Envitec Oxipen Pulse Oximeter And Accessories Ref K070193
Regimes: 510(k) Registry: 510(k)Envitec Mysign O Oxygen Measuring Device Ref K122290
Regimes: 510(k) Registry: 510(k)Mysign S Pulse Oximeter, Mysign Pc Software (Optional), Softtip Large R-3211-31, Finger Clip F-3211-31 Ref K133064
Regimes: 510(k) Registry: 510(k)Envitec Reusable Softip Y SPO2 Sensors Ref K060675
Regimes: 510(k) Registry: 510(k)Envitec Medical Oxygen Senors, Models OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 Ref K082655
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Envitec-Wismar GmbH have in the registry?
The registry currently lists 9 devices for Envitec-Wismar GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Envitec-Wismar GmbH's devices?
Among its 9 most recently registered devices, Envitec-Wismar GmbH has devices listed in FDA 510(k) (9 devices).
What risk classes do Envitec-Wismar GmbH's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Envitec-Wismar GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Envitec-Wismar GmbH in the registry?
The most recently registered devices listed for Envitec-Wismar GmbH include ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS, REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR, MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED and ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN.