Sauter AG
SwitzerlandFDA applicant, unverified
- Devices
- 5
What Sauter AG makes
Sauter AG manufactures steam sterilizers designed for medical and laboratory settings, including models like the BELIMED STEAM STERILIZER TOP 5000 (various series and configurations) and the MST-H and MST-V variants. These devices are engineered for high-temperature sterilization of instruments, equipment, and supplies using steam under pressure.
The company’s steam sterilizers are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States, where compliance with FDA requirements ensures their safety and performance for sterilization processes.
Catalogue
Belimed Steam Sterilizer Top 5000, Model 5-5-9 Ref K060337
Regimes: 510(k) Registry: 510(k)Belimed Steam Sterilizer Mst-H Ref K141879
Regimes: 510(k) Registry: 510(k)Belimed Steam Sterilizer, Model Top 5000 Ref K021223
Regimes: 510(k) Registry: 510(k)Belimed Steam Sterilizer Mst-V Ref K103841
Regimes: 510(k) Registry: 510(k)Belimed Steam Sterilizer Top 5000, Series 4 - 8 Ref K033538
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sauter AG have in the registry?
The registry currently lists 5 devices for Sauter AG. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sauter AG's devices?
Among its 5 most recently registered devices, Sauter AG has devices listed in FDA 510(k) (5 devices).
What risk classes do Sauter AG's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Sauter AG's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sauter AG in the registry?
The most recently registered devices listed for Sauter AG include BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9, BELIMED STEAM STERILIZER MST-H, BELIMED STEAM STERILIZER, MODEL TOP 5000 and BELIMED STEAM STERILIZER MST-V.