Lotus Bio, Ltd.
Country not established
- Devices
- 1
What Lotus Bio, Ltd. makes
Lotus Bio, Ltd. manufactures the SEAFORIA Sperm Separation Assistance System, a device designed to assist in isolating sperm cells from semen samples for fertility procedures.
The SEAFORIA system is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Seaforia Sperm Separation Assistance System Ref K112644
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Lotus Bio, Ltd. have in the registry?
The registry currently lists 1 device for Lotus Bio, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lotus Bio, Ltd.'s devices?
Among its 1 most recently registered device, Lotus Bio, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Lotus Bio, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Lotus Bio, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Lotus Bio, Ltd. in the registry?
The most recently registered devices listed for Lotus Bio, Ltd. include SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM.