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Sign in to claim this brandKaneka Pharma America Corp.
US
Last updated May 23, 2026
What Kaneka Pharma America Corp. makes
Kaneka Pharma America Corp. manufactures apheresis systems and associated components, including tubing sets for plasmapheresis, whole-blood filters, and dedicated apheresis machines. Their portfolio includes devices like the Liposorber LA-15 System, designed for therapeutic plasma exchange and lipid apheresis procedures.
The company’s devices are regulated under FDA pathways, with some classified as Class III and others as unclassified. Products are listed under the FDA’s Premarket Approval (PMA) and Unique Device Identifier (UDI) programs, reflecting their compliance with US medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
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- US
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Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tubing System For Plasmapheresis | NK-M3R(UL) | FDA UDI | Unclassified | Active |
| Apheresis Machine | KANEKA MA-03 | FDA UDI | Unclassified | Active |
| Sulflux | KP-05 | FDA UDI | Unclassified | Active |
| Tubing System For Plasmapheresis | NK-M3R(U) | FDA UDI | Unclassified | Active |
| Lacriflow CL | K170247 | FDA 510(k) | U | Active |
| Kaneka Pharma America Xpress-Way Rx | K101839 | FDA 510(k) | Class II | Active |
| Xpressway Rx Catheter (6f Ld-Verison) | K121301 | FDA 510(k) | Class II | Active |
| i-ED COIL | K192068 | FDA 510(k) | Class II | Active |
| LIPOSORBER LA-15 System | P910018 | FDA PMA | Class III | Active |
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