Gke-GmbH
GermanyFDA applicant, unverified
- Devices
- 1
What Gke-GmbH makes
Gke-GmbH manufactures the gke Steri-Record Steam Mini-Bio-Plus, a self-contained biological indicator (SCBI) designed for monitoring steam sterilization processes in medical and laboratory settings.
The company’s portfolio is regulated under FDA’s Class II device classification and is listed via the 510(k) premarket notification process. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gke-GmbH have in the registry?
The registry currently lists 1 device for Gke-GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gke-GmbH's devices?
Among its 1 most recently registered device, Gke-GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Gke-GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Gke-GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gke-GmbH in the registry?
The most recently registered devices listed for Gke-GmbH include gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI).