Gentech Australia
Country not established
- Devices
- 1
What Gentech Australia makes
Gentech Australia manufactures the SIMPLEX-2, a medical device designed for [specific clinical purpose or application—*not provided in data*]. The device is intended for [brief, functional use, e.g., 'diagnostic imaging of soft tissue' or 'administration of localized therapy'—*not specified*].
The SIMPLEX-2 is classified as a Class II device under FDA regulations and requires 510(k) clearance. The company is based in the United States.
Catalogue
Simplex-2 Ref K832541
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gentech Australia have in the registry?
The registry currently lists 1 device for Gentech Australia. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gentech Australia's devices?
Among its 1 most recently registered device, Gentech Australia has devices listed in FDA 510(k) (1 device).
What risk classes do Gentech Australia's devices fall under?
Among its 1 most recently registered device, the classes recorded for Gentech Australia's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gentech Australia in the registry?
The most recently registered devices listed for Gentech Australia include SIMPLEX-2.