Unisis

What Unisis does

Unisis Corp. Japan (株式会社ユニシス) is a privately held Japanese medical device company founded in 1978 and headquartered in Tokyo, specializing in the design, manufacture, and sale of specialty medical needles. Core products include spinal anesthesia needles (in K-3 Lancet, Pencil Point, Distal Fine, and Stiletto Point variants), epidural anesthesia needles and kits (Uniset, Uniset S/E, Uniset Pediatric), nerve block needles (including Echo-Genec echogenic variants), combined spinal-epidural (CSEA) needles, L.O.R. syringes, oocyte collection needles, surgical puncture needles, low-invasive micro injection and ophthalmic needles (31G/34G), low dead space syringes, artificial nose filters, and a veterinary line. Differentiated manufacturing IP includes Engrave加工 for ultrasound visibility, Distal Fine tip tapering with 2-gauge differential over a 7mm tip section for reduced dural damage, ultra-thin-wall tubing that delivers ~30% larger inner diameter for superior CSF recall-back, cobalt-reduced SUS304 stainless tubing for EU MDR compliance, and a patented catheter connector with dual-lock internal screw geometry; the company holds at least 17 registered patents across Japan, the US, and Europe.

The business operates a fully integrated 100% Japan-based manufacturing model across three sites — Saitama (mother factory, established 2004), Hokkaido (established 2014-2015 for BCP, expanded 2022), and Kyushu (under construction, opening Fall 2026) — supported by a network of cooperative companies from Hokkaido to Kyushu for parallel production. Products are sold under the UNIEVER trademark through (i) direct sales to hospitals, clinics, and anesthesia/pain specialists via domestic and overseas sales departments based in Tokyo, (ii) OEM/ODM manufacturing for major global medical device brands and dealers in approximately 50 countries, with 85%+ of production exported, and (iii) sales of co-developed alliance products such as artificial nose filters in Japan. Distribution relies heavily on in-person engagement at medical academic conferences (Japan Anesthesia Society, Japan Pain Clinic Society, etc.) and international exhibitions (MEDICA, Arab Health, KIMES, Hospitalar, Medical Fair Asia/India).

Revenue is not publicly disclosed. The company is family-controlled (Saito family; Eiya Saito serves as Representative Director since 2009), with 178 employees as of August 2025, ISO 13485 and ISO 9001 certifications (since 2003-2004, certified by SGS), FDA registration since 1996 with 510(k) clearances for spinal, epidural, and nerve block needles, CE marking since 2005 (under MDD, transitioning to MDR via TÜV Rheinland), GMP certification since 1995, ANVISA and KFDA approvals, and recognition as a METI Regional Future Driver Enterprise (2017).

Name

Unisis

Legal name

株式会社ユニシス

Website

https://unisis.co.jp

Company type

Private

Founded year

1978

Operating status

Operating

Headcount range

101–250 employees

Short description

Japanese medical device company designing, manufacturing, and selling specialty anesthesia and surgical needles (UNIEVER brand) plus OEM/ODM services. Operates fully integrated Japan-based manufacturing; exports 85%+ of output to ~50 countries serving hospitals, anesthesiologists, and global OEM medical device customers.

Ownership category

akta.pro rank

Product category

Medical Devices (Specialty Needles)

NAICS

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

SIC

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

akta.pro primary industry

Single-Use Surgical Devices & Procedure Packs (Disposable instruments, drapes, kits) (HLAHADAM)

akta.pro secondary industries

Open & Minimally Invasive Surgical Instruments (Handheld, Laparoscopic, MIS) (HLAHADAA), Surgical & Procedural Instruments (Scalpels, Forceps, Retractors) (HLAMAFAA), Practice Consumables & General Medical Supplies (Needles, Syringes, Gloves, Swabs) (HLAMAFAO)

Keywords

• Medical needles
• Anesthesia devices
• Spinal anesthesia needles
• Medical device manufacturing
• Veterinary needles

Headquarters

HQ city

Tokyo

HQ country

Japan

HQ region

Asia

Offices7 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Product Sales: Design, manufacture and sale of medical specialty needles including spinal anesthesia needles, epidural needles, nerve block needles, and related medical devices. Products sold under UNIEVER brand domestically and internationally. Over 85% of products are exported to approximately 50 countries worldwide.
2. OEM/ODM Manufacturing Services: Custom manufacturing services for other medical device manufacturers. Products manufactured as key devices for major global medical device companies, with regulatory expertise in CE (EU), FDA 510(k) (US), ANVISA (Brazil), KFDA (Korea) and other international certifications.
3. Alliance Products Sales: Sale of products from other companies (alliance products) co-developed or distributed, including artificial nose filters and other medical supplies to complement company's core needle product line.

Go-to-market motion3 records

Distribution channels5 records

Marketing channels4 records

Core offering

Unisis designs, develops, manufactures, and sells specialty disposable medical needles — including spinal, epidural, nerve block, spinal-epidural combined (CSEA), surgical puncture, oocyte collection, ophthalmic, and veterinary needles — together with anesthesia kits, simulators, and educational training models, marketed under the proprietary UNIEVER brand. The company also provides OEM/ODM contract manufacturing for global medical device brands.

Product overview

Unisis is a Japan-based medical device manufacturer specializing in medical needles and related surgical equipment. The company operates a fully integrated domestic manufacturing model and exports 85% of products to approximately 50 countries. The product portfolio centers on the UNIEVER brand and spans multiple product lines: (1) Anesthesia/Pain Clinic products including spinal anesthesia needles (K-3 Lancet Point, Pencil Point, Distal Fine, Stiletto Point variants), epidural anesthesia needles, nerve block needles (standard and Echo-Genec variants), combined spinal-epidural (CSEA) needles, epidural anesthesia kits (Uniset, Uniset S/E, Uniset Pediatric), continuous peripheral nerve block kits (Uniset PNB), and L.O.R. syringes for loss of resistance technique; (2) Respiratory/Filter products including artificial nose filters and bite blocks; (3) Obstetrics/Gynecology products including oocyte collection needles; (4) Cardiology products including surgical puncture needles; (5) Minimally Invasive products including micro injection needles (3-needle and single needle variants), ophthalmic needles, and low dead space syringes; (6) Veterinary products including injection needles, echo needles, infusion tube sets, spinal needles, zonde, and lacrimal duct irrigation needles; (7) Education products including spinal simulators, epidural simulators, and educational needle tip models (anesthesia and general medical versions); (8) Specialty needles including multi-purpose Chiba needles for PTCD applications. All products are manufactured in Japan under ISO 13485 quality management system with EOG sterilization capability.

Differentiator

Problem solved

Functional benefit

Products and services

• Disposable Spinal Anesthesia Needles (UNIEVER) Single-use spinal anesthesia needles available in multiple tip geometries (K-3 Lancet Point, Pencil Point, Distal Fine, Stiletto Point) under the UNIEVER brand, designed for atraumatic dural puncture and reduced post-dural puncture headache risk; for anesthesia departments of hospitals and surgical centers.
• Disposable Epidural Anesthesia Needle (UNIEVER) Single-use epidural anesthesia needle for epidural catheter placement, offering tactile feedback for loss-of-resistance technique; used by anesthesiologists in hospitals and obstetrics units.
• Disposable Spinal Epidural Combined Anesthesia Needle (CSEA) Single-use needle enabling combined spinal-epidural anesthesia (CSEA) in a single device; supports obstetric and surgical anesthesia workflows where both intrathecal and epidural access are needed.
• Disposable Nerve Block Needles (UNIEVER, including Echo-Genec variants) Single-use peripheral nerve block needles with echogenic tip options (Echo-Genec, Huber Echo-Genec) for ultrasound-guided regional anesthesia; for anesthesiologists performing peripheral nerve blocks.
• Epidural Anesthesia Kits (Uniset, Uniset S/E, Uniset Pediatric) Pre-assembled single-use epidural anesthesia kits combining the epidural needle with catheter, syringe, filter, and accessories; available in standard, S/E, and pediatric configurations for hospital anesthesia and obstetric use.
• Continuous Peripheral Nerve Block Kit (Uniset PNB) Single-use kit for continuous peripheral nerve block catheter placement, supporting prolonged regional anesthesia and postoperative pain control; for anesthesiologists and acute pain services.
• Disposable L.O.R. Syringe Single-use loss-of-resistance syringe for identifying the epidural space during epidural placement; complements Unisis epidural needles and kits.
• Disposable Artificial Nose Filter Single-use heat-and-moisture exchanger filter for anesthesia and intensive care respiratory circuits; used by anesthesiologists and ICU staff.
• Disposable Bite Block Single-use bite block for endoscopy and anesthesia procedures to protect oral structures and airway devices; for endoscopy suites and operating rooms.
• Disposable Oocyte Collection Needle Single-use needle for oocyte (egg) retrieval in IVF/ART procedures; designed for minimally traumatic follicular aspiration; for fertility clinics and reproductive medicine centers.
• Disposable Surgical Puncture Needle Single-use surgical puncture needle for tissue and fluid access in surgical procedures; for hospital surgical departments.
• Disposable Low-Invasive Micro Injection Needles (3-needle and Single-needle sets) Single-use minimally invasive micro injection needles available in 3-needle and single-needle configurations; for procedures requiring fine-gauge, low-trauma injection.
• Disposable Low-Invasive Ophthalmic Needle Single-use minimally invasive ophthalmic needle for ophthalmic surgery and intravitreal procedures; for ophthalmology departments and eye surgery centers.
• Disposable Syringe (Low Dead Space) Single-use low dead space syringe that minimizes residual medication volume; relevant where drug cost, dose accuracy, or waste reduction matters.
• Disposable Multi-Purpose Puncture Needle (Chiba Needle) Single-use Chiba-style multi-purpose puncture needle for general tissue and organ puncture procedures; for radiology, interventional, and surgical use.
• Veterinary Specialty Needle Line Single-use veterinary needles including injection needles, echo-guided needles, infusion tube sets, spinal needles, lacrimal duct irrigation needles, and Zonde probes; for veterinary clinics, animal hospitals, and veterinary teaching institutions.
• Spinal and Epidural Simulators (Training Devices) Reusable training simulators that replicate the tactile feel of spinal and epidural anesthesia procedures; for anesthesiology residency programs, medical schools, and clinical training centers.
• Educational Needle Tip Models Educational models illustrating needle tip designs for anesthesia and general medical training; used in medical education and clinician skill development.
• OEM/ODM Contract Manufacturing Services OEM/ODM manufacturing of specialty disposable medical needles and anesthesia devices for global medical device brands, leveraging Japan-based production, ISO 13485-certified quality systems, and proprietary needle technologies (Distal Fine, ultra-thin tube, engrave processing).

Quantifiable outcome

• Over 85% of products exported internationally to 50+ countries, demonstrating global market acceptance
• +3 more outcomes

Named customers4 records

Segments5 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

Four partnerships are on record, tiered core and moderate.

• MEDICA 2025 Joint Exhibition Partners (ベアーメディック, オーベクス, タスク, アルケア)coreGTM or Marketing Partner · 5 November 2024Joint exhibition at MEDICA 2025 (November 2025, Düsseldorf, Germany) with four Japanese medical device companies: Bear Medical, Obex, Task, and Alcare. Companies showcased respective strengths and products at combined booth to strengthen relationships and create new business opportunities with international partners and customers.
• 南部化成株式会社 (Southern Chemical Co., Ltd.)coreStrategic or Co-development Partner · 1 January 2018Business transfer of 4 products (manufacturing and sales) from Southern Chemical Co., Ltd. in 2018. This expanded company's product portfolio and manufacturing capabilities in related medical device areas.
• 国立研究開発法人日本医療研究開発機構 (AMED)moderateStrategic or Co-development Partner · 1 January 2017Approved for AMED subsidy project in 2017. Japan Agency for Medical Research and Development supports advanced medical research and development in Japan.
• Japan Cooperative Companies NetworkcoreOthersNetwork of cooperative companies across Japan (from Hokkaido to Kyushu) supporting manufacturing. All companies are excellent Japanese companies with superior product technology and quality response capabilities. Critical for BCP and parallel production capability to ensure stable supply even during disasters.

Scale indicators6 records

Recent moves14 records

Expansion highlights6 records

Direct peers

• Vygon: Vygon is a French specialty medical device manufacturer with a strong anesthesia, obstetrics, and neonatal needle portfolio (including spinal and epidural kits), competing with Unisis in European hospital channels and OEM supply arrangements.
• Pajunk: Pajunk is a German family-owned specialist manufacturer of regional anesthesia and nerve block needles with proprietary echogenic technology, directly competing with Unisis in the regional anesthesia niche and offering a comparable small-to-mid-cap specialty peer.
• Terumo: Terumo is a Japanese medical device major with overlapping anesthesia and injection needle product lines, sharing the domestic Japanese market with Unisis and competing in similar OEM and clinical sales channels across Asia.
• Smiths Medical (now ICU Medical): Smiths Medical (Portex brand), now part of ICU Medical, manufactures spinal, epidural, and nerve block needles globally with similar OEM and direct sales channels to Unisis, making it one of the closest direct comparables in specialty anesthesia needles.
• Nipro: Nipro is a Japanese medical device manufacturer with needles, syringes, and anesthesia products, directly comparable to Unisis in domestic Japanese market positioning and export channels across emerging and developed markets.
• B. Braun: B. Braun is a German global medical device leader with an extensive regional anesthesia needle portfolio (Spinocan, Perifix, Stimuplex) directly overlapping Unisis's spinal, epidural, and nerve block needle products, serving the same anesthesiologists and pain clinics worldwide.
• BD (Becton Dickinson): BD is a global medical technology leader with a broad needle and injection device portfolio (including anesthesia and specialty needles) competing directly with Unisis across hospital channels, particularly in North America and Europe where Unisis derives substantial export revenue.

Broad incumbents

• Sarstedt: Sarstedt is a German medical device manufacturer with a broad portfolio of needles, syringes, and clinical supplies, serving as a broader incumbent that overlaps with Unisis's specialty needle and OEM supply activities in European and global markets.
• Stryker (formerly NovaBay): Stryker is a large diversified medical device company with products and OEM capabilities intersecting specialty surgical needles and instruments used in the same operating room and pain clinic channels as Unisis products.

Emerging players

• Havel's: Havel's is a US-based specialty needle manufacturer focused on echogenic and regional anesthesia needles, representing an emerging competitor with technology overlap to Unisis's Engrave Processing/echogenic product line in the North American market.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/unisis-corp.

Compliance6 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 Unisis