Biomecca Australia, Ltd.
Country not established
- Devices
- 2
What Biomecca Australia, Ltd. makes
Biomecca Australia, Ltd. manufactures the Biomecca Caretaker 1000 and 2000, which are likely patient monitoring or support devices for critical care environments, and the Biomecca Central CS1, a central station system for managing patient data and alerts in healthcare settings.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
Biomecca Caretaker 1000 & 2000 Ref K860790
Regimes: 510(k) Registry: 510(k)Biomecca Central CS1 Ref K854639
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biomecca Australia, Ltd. have in the registry?
The registry currently lists 2 devices for Biomecca Australia, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biomecca Australia, Ltd.'s devices?
Among its 2 most recently registered devices, Biomecca Australia, Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Biomecca Australia, Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Biomecca Australia, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biomecca Australia, Ltd. in the registry?
The most recently registered devices listed for Biomecca Australia, Ltd. include BIOMECCA CARETAKER 1000 & 2000 and BIOMECCA CENTRAL CS1.