Regaltech Pty., Ltd.
AustraliaFDA applicant, unverified
- Devices
- 1
What Regaltech Pty., Ltd. makes
Regaltech Pty., Ltd. manufactures the Regaltech Maxiscope, a medical imaging device designed for high-resolution visualization of internal anatomical structures.
The Maxiscope is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Regaltech Maxiscope Ref K921163
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Regaltech Pty., Ltd. have in the registry?
The registry currently lists 1 device for Regaltech Pty., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Regaltech Pty., Ltd.'s devices?
Among its 1 most recently registered device, Regaltech Pty., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Regaltech Pty., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Regaltech Pty., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Regaltech Pty., Ltd. in the registry?
The most recently registered devices listed for Regaltech Pty., Ltd. include REGALTECH MAXISCOPE.