What Kawasumi Laboratories does

SB-KAWASUMI LABORATORIES, INC. (formerly Kawasumi Laboratories, Inc.) is a Japan-based medical device manufacturer and a wholly-owned subsidiary of Sumitomo Bakelite Co., Ltd., following the October 2021 succession of Sumitomo Bakelite's medical device business. The company designs, manufactures, and distributes disposable medical devices spanning the extracorporeal blood circulation and minimally invasive treatment value chain, organized into six business lines: hemodialysis (RENAK CTA cellulose triacetate dialyzers, A.V. fistula needles, blood circuits, physiologic saline), plasmapheresis (Evaflux plasma fractionators, Evacure/Evaclio/Plasmacure PE/Plasmacure plasma separators for therapeutic apheresis and DFPP), endovascular (Najuta and Najuta CMD thoracic stent graft systems for thoracic aortic aneurysm repair), infusion therapy (K-Shield Advantage winged blood collection sets with anti-needle stick protection), endoscopy (SB Knife dissection devices), and testing apparatus (endotracheal suction kits, sumius U-Container urine measurement devices). The company serves hospitals, dialysis centers, cardiovascular surgery centers, and apheresis treatment providers in more than 25 countries across Asia, Europe, North America, the Middle East, and Oceania, with manufacturing in Japan and (formerly) Thailand.

The company's technology base is anchored in polymer membrane science and minimally invasive device engineering, developed continuously since it introduced Japan's first coil-type dialyzer in 1972. Differentiated product features include CTA membrane biocompatibility with gamma sterilization, selective plasma fractionation via double filtration plasmapheresis with reduced substitution fluid requirements, and custom-made fenestrated stent graft systems designed from pre-operative CT imaging. Products are regulated under EU MDR (Regulation 2017/745) with CE marking for European distribution and the Japanese Pharmaceutical Affairs Act for domestic sale. The company holds two voluntary recalls in 2025–2026 (EGIS biliary stents and a disposable high-frequency knife) and announced discontinuation of certain saline products in 2026, alongside parallel capacity expansion for steering microcatheters.

The business model is B2B medical device sales through direct sales channels and a global distribution network to healthcare facilities, with no public pricing. Revenue is generated from hardware sales of single-use consumables and durable device systems across the six product lines. The company is a privately held subsidiary of Sumitomo Bakelite (parent listed on Tokyo Stock Exchange), so standalone financials are not disclosed. Patient reach is significant — the company states it serves over 2 million hemodialysis patients globally — and is recognized as a top-five key player in the continuous ambulatory peritoneal dialysis bags market.

Name

Kawasumi Laboratories

Legal name

SB-KAWASUMI LABORATORIES, INC.

Website

https://kawasumi.jp

Company type

Private

Founded year

1958

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

SB-KAWASUMI Laboratories is a Japanese medical device manufacturer (subsidiary of Sumitomo Bakelite) producing disposable hemodialysis, plasmapheresis, endovascular stent graft, infusion therapy, endoscopy, and testing products for hospitals and dialysis centers globally.

Ownership category

akta.pro rank

Product category

Medical Devices - Extracorporeal Blood Circulation

NAICS

Medical Equipment and Supplies Manufacturing (3391), Surgical Appliance and Supplies Manufacturing (339113)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Plasma Fractionation & Purification Manufacturing (HLAIAHAI)

akta.pro secondary industry

Infusion Pumps (Ambulatory/Stationary) (HLAHAIAF)

Keywords

• Hemodialysis dialyzers
• Plasmapheresis devices
• Endovascular stent grafts
• Blood collection sets
• Minimally invasive medical devices

Headquarters

HQ city

Minato

HQ country

Japan

HQ region

Asia

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Operations, Supply Chain, Technology or R&D, Personnel, Marketing or Sales, Infrastructure

Revenue model

1. Hemodialysis Products: Manufacture and sale of dialyzers, blood circuits, AVF needles, and physiologic saline for hemodialysis treatment. First Japanese coil-type dialyzer developed in 1972.
2. Plasmapheresis Products: Plasma separators, plasma fractionators, and other apheresis-related products for selective blood component separation.
3. Endovascular Products: Stent graft systems for thoracic aortic aneurysm treatment including Najuta Thoracic Stent Graft System and fenestrated stent graft variants.
4. Infusion Therapy Products: Infusion therapy products including winged blood collection sets with K-Shield Advantage needle safety technology. Product line established since 1958.
5. Testing Apparatus: Medical devices for testing including endotracheal suction kits and sumius U-Container for precise urine measurement. Kit approved under Pharmaceutical Affairs Act in 1983.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

SB-KAWASUMI manufactures and sells single-use medical devices for extracorporeal blood circulation and minimally invasive treatment. Core offerings include hemodialysis products (RENAK CTA dialyzers and AV fistula needles), plasmapheresis systems (Evaflux plasma fractionators, Evacure/Evaclio and Plasmacure PE plasma separators), endovascular devices (Najuta thoracic stent graft systems), and infusion therapy devices (K-Shield Advantage winged blood collection sets with anti-needle stick protection). Products are sold directly to hospitals, dialysis centers, cardiovascular surgery centers, and apheresis treatment providers in Japan and internationally.

Product overview

SB-KAWASUMI LABORATORIES (formerly Kawasumi Laboratories) is a medical device manufacturer and subsidiary of Sumitomo Bakelite Co., Ltd., offering a diversified portfolio of extracorporeal circulation and minimally invasive treatment products. The portfolio centers on hemodialysis products (RENAK CTA dialyzers, A.V. Fistula needles), plasmapheresis systems (Evaflux fractionators, Evacure/Evaclio separators, Plasmacure PE), and infusion therapy devices (K-Shield Advantage safety sets). Additional products include endovascular stent grafts (Najuta Thoracic systems), gastrointestinal endoscopy devices (SB Knife), and testing apparatus. The company positions itself in vascular access, blood purification, and minimally invasive surgical solutions, with global operations serving hemodialysis, plasmapheresis, and therapeutic apheresis markets. Products are regulated under EU MDR with CE marking for European distribution.

Differentiator

Problem solved

Functional benefit

Products and services

• RENAK CTA Dialyzer Cellulose Tri Acetate (CTA) membrane dialyzer for hemodialysis treatment, gamma-sterilized and available in 1.2m², 1.5m², and 2.0m² surface areas, offering excellent biocompatibility and effective removal of BUN, phosphate, and beta-2 microglobulin with minimal albumin loss. Used by dialysis centers and hospitals for chronic renal failure patients.
• A.V. Fistula Needle Arteriovenous fistula needles for hemodialysis vascular access, available in standard and painless needle variants, with gamma sterilization, unique bevel design to minimize tissue damage, silicone application technology for smooth cannulation, and optional anti-stick safety devices. Used by dialysis clinicians and nurses.
• Evaflux Plasma Fractionator Plasma fractionator for Double Filtration Plasmapheresis (DFPP) enabling selective depletion of high molecular weight plasma components based on molecular size with reduced or no requirement for substitution fluid. Used in apheresis treatment providers for familial hypercholesterolemia, autoimmune neurological disorders, and ABO/HLA incompatible kidney transplantation.
• Evacure / Evaclio Plasma Separator High-volume selective plasma exchange separator with smaller pore size that removes small and medium molecular weight proteins while retaining large molecular weight proteins, offering plasma substitute fluid saving with two membrane types available for different target substances. Used by therapeutic apheresis providers.
• Plasmacure PE Plasma Separator Ethylene vinyl alcohol copolymer hydrophilic membrane-coated polyethylene hollow fiber plasma separator with stable filtration property, gamma ray sterilized (ETO free), and consistent performance due to minimal TMP increase. Used by therapeutic apheresis providers.
• Cascadeflo EC Plasma Component Separator Plasma component separator for therapeutic apheresis procedures, CE marked under Regulation (EU) 2017/745 (MDR) for medical devices. Used by European apheresis providers.
• Rheofilter ER Plasma Component Separator Plasma component separator for therapeutic apheresis procedures, CE marked under Regulation (EU) 2017/745 (MDR) with control number CE RHR-00. Used by European apheresis providers.
• K-Shield Advantage Winged Blood Collection Sets Winged blood collection sets with integrated K-Shield Advantage anti-needle stick protector, featuring simple one-step activation and compact design suitable for hospital use. Developed in response to U.S. anti-needle stick safety device requirements and highly evaluated in the U.S. market. Used by hospital infusion therapy and blood collection departments.
• Najuta Thoracic Stent Graft System Thoracic aortic aneurysm treatment device using endovascular stent graft technology with a spring-like metal stent attached to an artificial graft, folded and filled in a low-profile catheter. Provides a less invasive alternative to open surgical repair, particularly for elderly and high-risk patients. Used by cardiovascular surgery centers.
• Najuta CMD Thoracic Stent Graft System Custom-made fenestrated thoracic stent graft system designed based on pre-operative CT diagnosis for complex aortic anatomies near vessel bifurcations. Used by cardiovascular surgeons for endovascular aneurysm repair.
• SB Knife Endoscopic dissection knife for gastrointestinal endoscopy procedures, part of the company's minimally invasive treatment portfolio. Used by gastroenterology and endoscopy departments.
• Endotracheal Suction Kit Aseptic collection device for testing respiratory secretions from bronchi, trachea, and oral cavity, with a centrifuge tube directly attached to a connecting tube for fiberoptic scope compatibility. Used by respiratory and pulmonary testing departments.
• sumius U-Container Precise proportional urine measurement device for 1/50 ratio collection of 24-hour daily urination, used for hypertension diagnostic dietary instructions and treatment monitoring for diabetes, kidney, and endocrine diseases. Used by clinical testing departments.

Named customers1 record

Segments5 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

One partnership is on record.

• Sumitomo Bakelite Co., Ltd.coreStrategic or Co-development Partner · 1 October 2021SB-KAWASUMI is an affiliate of Sumitomo Bakelite Co., Ltd. The medical device business was successioned from Sumitomo Bakelite Co., Ltd. on October 1, 2021, with the company name changing from Kawasumi Laboratories, Inc. to SB-KAWASUMI LABORATORIES, INC. Sumitomo Bakelite serves as the parent company within the group structure.

Scale indicators4 records

Recent moves10 records

Expansion highlights5 records

Direct peers

• Baxter International: Major peritoneal and hemodialysis product manufacturer that competes directly with Kawasumi in dialysis bags and disposable blood treatment sets; cited as the 31% share leader in the CAPD bags market.
• Nipro Corporation: Japanese medical device manufacturer with a sizable dialysis disposables business including dialyzers, blood lines, and AV fistula needles that compete with Kawasumi's hemodialysis portfolio.
• Fresenius Medical Care: Global leader in dialysis products and services, manufacturing dialyzers, blood lines, and related extracorporeal circulation disposables directly comparable to Kawasumi's hemodialysis portfolio.
• Haemonetics Corporation: Specialist in apheresis and plasma collection systems, comparable to Kawasumi's Evaflux, Evacure, and Cascadeflo plasmapheresis product family for therapeutic apheresis.
• B. Braun: German medical device company with hemodialysis, infusion therapy, and blood collection product lines comparable to Kawasumi's dialysis and infusion/blood collection portfolio.
• Toray Medical: Japanese manufacturer of hollow-fiber dialyzers and artificial kidneys, directly overlapping with Kawasumi's RENAK CTA dialyzer line and other hemodialysis offerings.
• Asahi Kasei Medical: Japanese manufacturer of dialysis membranes (e.g., APS, VIE series), plasma fractionation filters, and apheresis devices, overlapping closely with Kawasumi's hemodialysis and plasmapheresis product lines.

Broad incumbents

• Terumo Corporation: Large Japanese medical device leader with blood component collection, infusion, and interventional product lines that overlap with Kawasumi's infusion therapy and endovascular categories, though Terumo operates across a much broader portfolio.
• Sumitomo Bakelite Co., Ltd. Parent company of SB-KAWASUMI; a diversified Japanese conglomerate whose medical device business was successioned into Kawasumi in 2021, sharing historical R&D and manufacturing roots.

Regional players

• JMS Co., Ltd. Japanese medical device manufacturer focused on infusion, blood collection, dialysis, and enteral nutrition products; a regional peer with direct overlap in infusion therapy and dialysis disposables sold primarily in Asia.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• YouTubeyoutube.com/channel/UCkc8xkZj2N2gTKZ7ZPACsXQ/featured
• LinkedInlinkedin.com/company/kawasumi-laboratories-inc-7703-

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments1 record

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Kawasumi Laboratories