Omi Manufacturing Pty., Ltd.
Country not established
- Devices
- 2
What Omi Manufacturing Pty., Ltd. makes
Omi Manufacturing Pty., Ltd. produces the Personna Plus Safety Scalpel System, a blade-handling device designed to reduce sharps injuries in surgical settings, and a range of retractable safety syringes for single-use medical injections, featuring built-in needle protection mechanisms.
The company’s devices are classified under FDA categories Class I and Class II, with relevant products listed via the 510(k) pathway. The manufacturer operates from the United States.
Catalogue
Personna Plus Safety Scalpel System Ref K032242
Regimes: 510(k) Registry: 510(k)Omi Retractable Saftey Syringe, Various Ref K060971
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Omi Manufacturing Pty., Ltd. have in the registry?
The registry currently lists 2 devices for Omi Manufacturing Pty., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Omi Manufacturing Pty., Ltd.'s devices?
Among its 2 most recently registered devices, Omi Manufacturing Pty., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Omi Manufacturing Pty., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Omi Manufacturing Pty., Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Omi Manufacturing Pty., Ltd. in the registry?
The most recently registered devices listed for Omi Manufacturing Pty., Ltd. include PERSONNA PLUS SAFETY SCALPEL SYSTEM and OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS.