Haemocell PLC
United KingdomFDA applicant, unverified
- Devices
- 1
What Haemocell PLC makes
Haemocell Plc manufactures the Haemocell System 350 (S350), a medical device designed for blood processing and cellular therapy applications, including apheresis procedures.
The device is classified as Class II under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Haemocell System 350 Or S350 Ref K960734
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Haemocell Plc have in the registry?
The registry currently lists 1 device for Haemocell Plc. Devices recorded under merged duplicate company entries are counted once.
Which registries list Haemocell Plc's devices?
Among its 1 most recently registered device, Haemocell Plc has devices listed in FDA 510(k) (1 device).
What risk classes do Haemocell Plc's devices fall under?
Among its 1 most recently registered device, the classes recorded for Haemocell Plc's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Haemocell Plc in the registry?
The most recently registered devices listed for Haemocell Plc include HAEMOCELL SYSTEM 350 OR S350.