Fuji Systems

What Fuji Systems does

Fuji Systems Corporation (富士システムズ株式会社) is a Japanese medical device manufacturer founded in 1963 and headquartered in Tokyo, operating as a subsidiary of holding company Fuji Systems HD Corporation with Shin-Etsu Chemical Co., Ltd. as a strategic shareholder since 1985. The company is the world's first developer of silicone-based medical devices, originating with silicone catheters and silicone gauze in 1958, and now offers 3,000+ product SKUs across 14+ clinical specialties under the PHYCON brand. Its proprietary technology centers on silicone polymer processing, including extrusion, press molding, injection molding, LIM molding, and dip molding, with specialized capabilities in gas barrier balloon coatings, silver-based antimicrobial catheters, hydrophilic surface treatments, and silicone hollow fiber membranes for gas exchange applications including artificial lungs.

The company generates revenue through four streams: proprietary silicone medical device sales (catheters, endotracheal tubes, gastrostomy tubes, cardiac cannulae, neurosurgical devices), OEM/ODM contract manufacturing for other medical device manufacturers with Class IV regulatory capability, import and distribution of component parts from international brands (QOSINA, ACUMEN Surgical, Excel Medical Products, LISTAL) to Japanese manufacturers, and licensing/technology transfer from joint research. Domestically, sales are conducted through eight regional branch offices covering every Japanese prefecture, supported by the Shirakawa manufacturing plant in Fukushima and the Kansai Distribution Center in Hyogo. International sales flow through a distributor network including Medtronic (global CELLO balloon guide catheter), Ambu (USA/Canada airway management), and regional partners across South Korea, Taiwan, Indonesia, and Thailand, reaching markets in Asia, Europe, North America, South America, the Middle East, and Africa.

Fuji Systems holds ISO 13485:2016, EU MDR 2017/745 CE marking, MDSAP certification, and US FDA approval for the CELLO Balloon Guide Catheter. It maintains long-standing joint research partnerships with seven Japanese universities (Tokyo, Kyoto, Tohoku, Kyushu, Kagawa, Nagasaki, Tokyo University of Science) plus Cleveland Clinic and Baylor College of Medicine for artificial organ development. The company's product range spans neurosurgery (ventricular drains, shunts, CSF reservoirs), neurovascular intervention (CELLO), anesthesiology (UNIVENT, UNIBLOCKER, SILBRONCHO endobronchial tubes), urology (SELFCATH self-catheterization), gastroenterology (GB gastrostomy balloon series), cardiovascular surgery (SP-GRIPFLOW, AP-GRIPFLOW, MINI SHUNT PRO cannulae), and respiratory care, with OEM services extending these capabilities to third-party manufacturers worldwide.

Name

Fuji Systems

Legal name

富士システムズ株式会社 (Fuji Systems Corporation)

Website

https://fujisys.co.jp

Company type

Private

Founded year

1963

Operating status

Operating

Headcount range

251–500 employees

Short description

Fuji Systems is a Japanese medical device manufacturer founded in 1963 and the world's first developer of silicone-based medical devices, producing 3,000+ SKUs across neurosurgery, anesthesiology, urology, gastroenterology, and cardiovascular specialties for hospitals, OEMs, and international distributors.

Ownership category

akta.pro rank

Product category

Silicone Medical Devices

NAICS

Surgical Appliance and Supplies Manufacturing (339113), Surgical and Medical Instrument Manufacturing (339112), Medical Equipment and Supplies Manufacturing (3391)

SIC

Surgical & Medical Instruments & Apparatus (3841), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)

akta.pro primary industry

Single-Use Medical Disposables & Procedure Kits (Drapes, Tubing, Catheters, Syringes, Custom Packs) (HLAHANAG)

akta.pro secondary industries

Open & Minimally Invasive Surgical Instruments (Handheld, Laparoscopic, MIS) (HLAHADAA), Medical & Life Sciences Injection Molding (Devices, Diagnostics, Cleanroom) (IMANAFAC), Single-Use Systems Assembly & Consumables Manufacturing (Bags/Tubing/Assemblies) (HLAGAGAH)

Keywords

• Silicone medical devices
• Catheter manufacturing
• Medical device OEM
• Endotracheal tubes
• Gastrostomy devices

Headquarters

HQ city

Tokyo

HQ country

Japan

HQ region

Asia

Offices11 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Proprietary silicone medical device sales: Research, development, manufacturing, and sales of proprietary silicone-based medical devices under the PHYCON brand. Products include catheters for neurosurgery, anesthesiology, urology, gastroenterology, cardiovascular surgery, and more. Sold domestically through regional branches and internationally through distributors.
2. OEM/ODM manufacturing services: Contract development and manufacturing of silicone-based medical devices and components for other medical device manufacturers. Services span specification review, design, prototyping, regulatory approval (up to Class IV), mass production, and EOG sterilization. Includes components such as molded silicone products, silicone tubes, antimicrobial catheters, hydrophilic-coated catheters, and sterile surgical products.
3. Component/parts distribution: Import and sale of component parts from international manufacturers including QOSINA (USA, connectors, caps, one-way valves), ACUMEN Surgical (Pakistan, steel instruments), Excel Medical Products (USA, Y-connectors), and LISTAL (Ireland, IV filters). Sold to domestic Japanese medical device manufacturers.
4. Licensing and technology transfer: Joint research arrangements with medical institutions and universities. The company develops and licenses technology and know-how in exchange for research collaboration and product commercialization rights.

Go-to-market motion3 records

Distribution channels4 records

Marketing channels5 records

Core offering

Fuji Systems manufactures and sells a broad portfolio of proprietary silicone-based medical devices (catheters, endotracheal tubes, gastrostomy tubes, bronchial blockers, balloon guide catheters, surgical cannulae, and wound care products) under its PHYCON brand, serving 14+ clinical specialties. Beyond proprietary products, the company provides OEM/ODM contract design and manufacturing services to other medical device manufacturers and distributes imported medical device components (connectors, valves, IV filters, instruments) from QOSINA, ACUMEN, Excel Medical Products, and LISTAL.

Product overview

富士システムズは1963年の創業以来、世界で初めてシリコラーを活用した医療機器を開発した企業として、主力ブランド「ファイコン（PHYCON）」を中心に3,000品目以上のシリコラー製医療機器を展開する。主力製品は、カテーテル類、気管内チューブ、胃瘻チューブ、人工肺膜素材など。製品は脳神経外科、耳鼻咽喉科、麻酔科、呼吸器科、消化器科、心臓血管外科、泌尿器科、肾脏内科、産婦人科、皮膚科など幅広い診療領域にわたる。ブランド製品にはUNIBLOCKER™、UNIVENT™、SILBRONCHO™、CELLO™、SP-GRIPFLOW™、AP-GRIPFLOW™、SELFCATH™、GB胃瘻シリーズ、耳管ピン、GILBRANE®（人工肺素材）等がある。OEM/ODMサービスでは独自技術（ガスバリア性シリコラーур баллонン、抗菌剤含有カテーテル、親水性コート等）を客户提供。此外、公司还经营QOSINA、ACUMEN、LISTAL等海外品牌组件产品的进口销售业务。公司产品在日本国内、亚洲、欧洲、北美、南美、中东、非洲等地均有销售网络。

Differentiator

Problem solved

Functional benefit

Products and services

• PHYCON Brand Silicone Medical Devices (ファイコン ブランド製品群) The company's flagship silicone medical device brand covering 3,000+ products across 14+ clinical specialties — neurosurgery, ENT, anesthesiology, respiratory, gastroenterology, cardiac surgery, urology, nephrology, obstetrics/gynecology, and dermatology — including catheters, endotracheal tubes, gastrostomy tubes, artificial lung materials, and other silicone devices for medical institutions.
• UNIBLOCKER™ (Single-lung ventilation bronchial blocker) Endobronchial blocker-type single-lung ventilation device enabling lung collapse during thoracic surgery. Features torque-controlled mechanism and latex-free design, with 5Fr and 9Fr sizes for anesthesiologists and thoracic surgeons.
• UNIVENT™ (Endobronchial tube) Endobronchial tube for one-lung ventilation enabling lung isolation during thoracic surgery. Available in adult and pediatric versions. Inserted via endotracheal route and used for selective lung ventilation.
• SILBRONCHO™ (100% Silicone Double-Lumen Endobronchial Tube) 100% silicone double-lumen tube for one-lung ventilation during thoracic surgery. Soft flexible silicone tip and wire-reinforced design to prevent kinking, with left and right endobronchial tube types available.
• CELLO™ (Balloon Guide Catheter) Balloon guide catheter for intravascular catheter insertion and induction in neurovascular and peripheral vascular systems. US FDA-approved in 2012 and CE-marked; available in 6F–9F sizes. Distributed globally by Medtronic.
• SELFCATH™ (Self-Catheterization Catheter) Japan's first self-catheterization catheter, made of medical-grade silicone rubber. Disposable in plastic case with disinfection liquid for safe management. Available in pediatric, female, and male versions for urology patients.
• GB Gastrostomy Balloon Tube and Button Series Gastrostomy silicone balloon catheter and button for enteral nutrition with large-diameter connector design. ISO 80369-3 compliant for misconnection prevention. Available in mixed-food-supporting large-diameter types for gastrostomy patients.
• SP-GRIPFLOW™ and AP-GRIPFLOW™ (Surgical Cannulae with grid-like ribbed silicone balloon) Antegrade arterial perfusion cannula and descending thoracic aortic aneurysm cannula with grid-like ribbed silicone balloon surface to prevent slipping and ensure cerebroprotection during aortic arch aneurysm surgery. AP-GRIPFLOW features special silicone balloon with suspension shaft; available in 21Fr, 24Fr, and 28Fr sizes.
• MINI SHUNT PRO (Small Silicone Cannula) Small silicone cannula for temporary blood flow support from coronary artery to peripheral vessel during coronary artery bypass surgery. Flexible silicone tip cannula enables easy insertion and removal into small peripheral vessels.
• Endotracheal Tube Wire Reinforced Wire-reinforced endotracheal tube with silicone collar for optimal flexibility, designed to prevent kinking and blockage for intubation in anesthesiology procedures.
• Tracheostomy Tube with GB Cuff Tracheostomy tube with gas barrier (GB) cuff. Specially processed gas barrier cuff stabilizes internal pressure and suppresses water loss for long-term use, featuring a medical silicone collar.
• Ventricular Drainage Tube Ventricular drainage tube for external ventricular drainage in neurosurgery, available in multiple sizes and inner diameters with various side hole configurations for CSF drainage.
• L-P Shunt Set (Lumboperitoneal Shunt) Lumboperitoneal shunt set for ventriculo-peritoneal shunt systems, available in low, medium, and high pressure peritoneal tube variants for hydrocephalus treatment in neurosurgery.
• Cerebrospinal Fluid Reservoir AT CSF (cerebrospinal fluid) reservoir for transcutaneous (puncture) use in neurosurgery, available in 12φ and 10φ puncture sizes for CSF sampling and monitoring.
• TREX™ Silicone Gauze World's first non-stick silicone gauze made from porous synthetic fiber coated with silicone rubber. Used as a wound dressing for burns and decubitus ulcers, available in multiple sizes for dermatology and wound care.
• Ear Pin (Eustachian Tube) Microscopic silicone ear pin (Eustachian tube) for otitis media treatment that narrows the Eustachian tube connecting from the tympanic cavity cavity opening to the nasal cavity. Available in various tip widths for ENT specialists.
• GILBRANE® Silicone Hollow Fiber Gas Exchange Devices Silicone rubber sheet, silicone hollow fiber, artificial gill, and gas exchange device products. Small-membrane-type oxygenator enabling gas exchange at the molecular level, with R&D progressing toward artificial lung applications.
• Medical Device OEM/ODM Contract Manufacturing Services OEM/ODM contract development services for silicone-based medical devices, manufactured in ISO 13485-certified domestic facilities. Supports Class IV regulatory applications, with proprietary technology offerings including gas barrier silicone balloons, antimicrobial-agent-containing catheters, and hydrophilic-coated catheters for other medical device manufacturers.
• Imported Medical Device Component Parts (QOSINA, ACUMEN, LISTAL, Excel Medical Products) Import and domestic sale of medical device component parts — connectors, pinsets, clamps, luer connectors, caps, one-way valves, Y-connectors, IV filters, and stainless steel instruments — from QOSINA (USA), ACUMEN (Pakistan), Excel Medical Products (USA), and LISTAL (Ireland), supplied with Japanese medical device registrations to domestic manufacturers.

Quantifiable outcome

• World's first silicone catheter developed in 1958; world's first silicone gauze (TREX) developed in 1958
• +2 more outcomes

Named customers8 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

19 partnerships are on record, tiered core and flagship.

• Baylor College of Medicine (USA)coreStrategic or Co-development Partner · 1 January 1996Joint research on artificial lungs starting 1996, combining Baylor's medical expertise with Fuji Systems' silicone hollow fiber technology.
• Tokai University School of MedicineflagshipStrategic or Co-development Partner · 1 January 1981Collaborative development of the revolutionary UNIVENT endobronchial tube enabling one-lung ventilation. The 1981 collaboration resulted in the first left upper lung lobectomy using UNIVENT tubes and was the origin of Fuji Systems' leading position in one-lung ventilation devices.
• Nagoya UniversitycoreStrategic or Co-development Partner · 1 January 1979Participated in space shuttle/spacelab life science experiments with Nagoya University, exploring applications of silicone technology in space medicine.
• Cleveland Clinic (USA)coreStrategic or Co-development Partner · 1 January 1974Joint development of artificial lungs and membranes starting 1974 with the Cleveland Clinic, one of the world's leading medical institutions.
• MedtronicflagshipChannel Partner/ Reseller/ DistributorGlobal distribution partner for Fuji Systems' CELLO Balloon Guide Catheter for neurovascular intervention. Medtronic distributes CELLO products in the USA, EU, and globally under its AIS Revascularization Products line.
• AmbucoreChannel Partner/ Reseller/ DistributorUS and Canadian distributor for Fuji Systems' one-lung ventilation products (UNIBLOCKER, UNIVENT, SILBRONCHO) under Ambu's airway management and anaesthesia portfolio.
• Young Ming Medical Co., LTD.coreChannel Partner/ Reseller/ DistributorSouth Korea distributor for Fuji Systems' products.
• BIOTRONIC Instrument Enterprise Ltd.coreChannel Partner/ Reseller/ DistributorTaiwan distributor for Fuji Systems' UNIBLOCKER endobronchial blocker products through BIOTRONIC's airway device distribution network.
• PT NITRAcoreChannel Partner/ Reseller/ DistributorIndonesia distributor for Fuji Systems' neurosurgery products.
• MEDITOP Co., Ltd.coreChannel Partner/ Reseller/ DistributorThailand distributor for Fuji Systems' urology products (SELFCATH).
• QOSINAcoreTechnology or IntegrationUS-based manufacturer (founded 1980) of medical, pharmaceutical, laboratory, and cosmetic component parts. Fuji Systems distributes QOSINA components (connectors, caps, one-way valves, clamps, luer connectors) in Japan. A distributor change notice was issued in August 2025.
• University of TokyoflagshipStrategic or Co-development PartnerLong-standing joint research partner since 1963. Currently collaborating on artificial lung development (started 2017). Fuji Systems contributed to the development of Japan's first domestically-produced silicone artificial heart.
• Kagawa UniversitycoreStrategic or Co-development PartnerAcademic joint research partner in medical device development.
• Kyushu UniversitycoreStrategic or Co-development PartnerAcademic joint research partner in medical device development.
• Kyoto UniversitycoreStrategic or Co-development PartnerAcademic joint research partner in medical device development.
• Tokyo University of SciencecoreStrategic or Co-development PartnerAcademic joint research partner in medical device development.
• Tohoku UniversitycoreStrategic or Co-development PartnerAcademic joint research partner in medical device development.
• Nagasaki UniversitycoreStrategic or Co-development PartnerAcademic joint research partner in medical device development.
• Japan Artificial Organ Research Institute (JAOR)Strategic or Co-development PartnerJoint initiative established in 1974 for artificial organ research and development, combining Fuji Systems' silicone technology with clinical and academic expertise.

Scale indicators5 records

Recent moves10 records

Expansion highlights5 records

Broad incumbents

• Becton Dickinson (BD): BD is a diversified medical technology leader with extensive catheter, injection, and surgical device portfolios. As a broad incumbent, BD serves the same hospital customers as Fuji Systems but at significantly larger scale across many product categories.
• Smiths Medical: Smiths Medical (now part of ICU Medical) offers airway management, infusion, and vascular access devices. Its endotracheal tubes and tracheostomy products directly overlap with Fuji Systems' PHYCON anesthesiology product line, serving the same clinical specialists.
• Cardinal Health (Medical Products): Cardinal Health distributes a broad portfolio of medical and surgical products including catheters, surgical instruments, and OEM/ODM medical devices to hospitals. Comparable to Fuji Systems as a hospital-channel medical device manufacturer and distributor in the surgical and consumables space.

Direct peers

• Coloplast: Coloplast is a global leader in ostomy care, continence care (including intermittent self-catheterization), and wound care. Fuji Systems' SELFCATH self-catheterization line and gastrostomy balloon tubes directly overlap with Coloplast's core urology and ostomy franchises.
• Cook Medical: Cook Medical specializes in interventional radiology, vascular, and urology devices including catheters and minimally invasive surgical products. Strongly comparable to Fuji Systems' CELLO neurovascular balloon guide catheter and SELFCATH self-catheterization franchises.
• ConvaTec: ConvaTec is a global medical products company focused on ostomy care, continence care, and advanced wound care. Its intermittent catheters and gastrostomy devices directly overlap with Fuji Systems' SELFCATH and GB Gastrostomy Balloon product lines.
• Hollister Incorporated: Hollister manufactures ostomy, continence (intermittent catheters), and wound care products globally. Its self-catheterization and ostomy franchises directly mirror Fuji Systems' SELFCATH and GB Gastrostomy Balloon offerings, serving the same urology and gastroenterology patient populations.
• Ambu: Ambu is a Danish medtech leader in single-use airway management, endoscopy, and patient monitoring. Ambu is also Fuji Systems' North American distribution partner for airway devices, making it a direct peer in one-lung ventilation while serving overlapping anesthesiology and pulmonology end markets.
• Teleflex: Teleflex is a global medical device company with a strong portfolio in airway management (endotracheal tubes, bronchial blockers) and surgical instruments. Directly comparable to Fuji Systems' UNIVENT/UNIBLOCKER/SILBRONCHO one-lung ventilation franchise and other surgical specialty products, serving the same hospital and anesthesia customers.
• ICU Medical: ICU Medical manufactures medical connectors, catheters, and critical care devices. Its catheter and infusion portfolio overlaps with Fuji Systems' silicone catheter and OEM/ODM offerings for hospitals and IV therapy markets.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds

Investors

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

M&A

Investments

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

Frequently asked questions about Fuji Systems