Hemocleanse, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Hemocleanse, Inc. makes
Hemocleanse, Inc. manufactures blood purification systems, including the BIOLOGIC-DT machine and treatment kits for extracorporeal therapies. Their portfolio includes the THERMOCHEM-HT system and integrated BIOLOGIC-DT systems combining the DT-1000 machine with its treatment kit. These devices are designed for therapeutic blood filtration and detoxification procedures.
The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The portfolio is regulated in the United States, where Hemocleanse, Inc. is based.
Catalogue
Biologic Dt-1000 Machine Ref K923046
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Thermochem-Ht System Ref K993330
Regimes: 510(k) Registry: 510(k)Biologic-Dt System Ref K953751
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hemocleanse, Inc. have in the registry?
The registry currently lists 5 devices for Hemocleanse, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hemocleanse, Inc.'s devices?
Among its 5 most recently registered devices, Hemocleanse, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Hemocleanse, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Hemocleanse, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hemocleanse, Inc. in the registry?
The most recently registered devices listed for Hemocleanse, Inc. include BIOLOGIC DT-1000 MACHINE, BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK, THERMOCHEM-HT SYSTEM and BIOLOGIC-DT SYSTEM.