Sterilance Medical

What Sterilance Medical does

Sterilance Medical (苏州施莱医疗器械有限公司 / SteriLance Medical (Suzhou) Inc.) is a privately-held Chinese medical device manufacturer founded in 1993 by Shi Yinggan in Suzhou, Jiangsu Province. The company designs, develops, manufactures and sells three core product families: peripheral blood collection devices (safety lancets in Press, Press Plus, Impress, Elite, Elite Pro, Lite3, Lite4 and Flex3 variants; reusable LDE4 lancing pens; Soft, SoftSure and Soft5 lancet needles; and the 2024-launched NANOSense/SoftSense one-step loading system), surgical instruments (sterile surgical blades, plastic-handle and safety scalpels such as Index Asurity, mini scalpels, suture cutters, skin graft knives and podiatry blades), and insulin injection pen needles (Easydrip Plus/Classic/Classic Pro, with the Sandstone Medical sub-brand including the Hextra Tech hexagonal-hub design). SteriHeel Plus newborn heel incision devices, allergy testing puncture needles and alcohol pads round out the consumables portfolio. Manufacturing is anchored in three Suzhou facilities (Huqiu 2000, Xiangcheng 2003, Science City HQ 2020) with automated production, inline imaging inspection, and gamma-ray sterilization with a 5-year shelf life.

SteriLance operates a hybrid OEM/ODM-plus-own-brand model. It is an authorized OEM supplier for global blood glucose meter brands including a 10+ year partnership with Roche Diabetes Care (manufacturing Soft5-type lancets compatible with Roche Softclix lancing pens), while also selling SteriLance, Sandstone Medical, 妙指 (Miao Zhi) and Easydrip branded products through a global distributor and dealer network reaching 50+ countries and over 5,000 enterprise customers. A wholly-owned US sales subsidiary, SteriLance Medical (USA) Inc., operates from Duluth, Georgia (est. 2009), and the insulin pen needle product line was spun off into wholly-owned Suzhou Shali Medical Equipment Co., Ltd. in 2018. Revenue is generated via hardware sales at undisclosed, quotation-based pricing; the company does not currently sell directly to end consumers through e-commerce.

The business is regulated under a comprehensive global certification stack - ISO 13485:2016, MDSAP, EU CE MDR 2017/745, US FDA 510(k), China NMPA, Japan FMR, UK MHRA, and Canada MDL Category II - and holds over 200 global patents (2025), 124 registered trademarks and 88 international trademarks. Strategic positioning is supported by the 2022 Suzhou Quality Award, the 22nd China Patent Excellence Award (2021), High-Tech Enterprise accreditation (2017), and Provincial Famous Export Brand Enterprise (2016). No external institutional funding rounds, parent company, or public listing have been disclosed.

Name

Sterilance Medical

Legal name

苏州施莱医疗器械有限公司

Website

https://sterilance.com

Company type

Private

Founded year

1993

Operating status

Operating

Headcount range

501–1,000 employees

Short description

Sterilance Medical is a privately-held Suzhou-based Chinese manufacturer founded in 1993 that designs, produces and sells safety lancets, lancing devices, surgical blades, and insulin pen needles for global OEM partners, hospitals, and diabetes-care distributors across 50+ countries.

Ownership category

akta.pro rank

Product category

Capillary Blood Collection Medical Devices

NAICS

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

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)

Keywords

• Blood collection devices
• Safety lancets manufacturing
• Insulin pen needles
• Surgical blades
• Medical device OEM

Headquarters

HQ city

Suzhou

HQ country

China

HQ region

Asia

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Manufacturing & Sales: SteriLance generates revenue from designing, developing, manufacturing, and selling three main product categories: peripheral blood collection devices (末梢采血器), surgical blade instruments (外科手术刀), and insulin injection pen needles (胰岛素注射针). The company operates primarily as an OEM/ODM supplier and also under its own SteriLance brand, selling to global distributors, hospitals, and blood glucose meter brand partners.

Go-to-market motion3 records

Distribution channels4 records

Marketing channels5 records

Core offering

Sterilance Medical designs, develops, manufactures and sells single-use medical devices for capillary blood collection, surgical procedures and insulin injection. Its core offerings are grouped into three categories: (1) peripheral blood collection products — safety lancets (Press, Press Plus, Impress, Elite, Elite Pro, Lite3, Lite4, Flex3), reusable lancing devices (LDE4, NANOSense), and disposable lancet needles (Soft, SoftSure, Soft5, SoftSense); (2) surgical instruments — sterile surgical blades, Index Asurity safety scalpels, plastic handle scalpels, mini scalpels, suture cutters, skin graft knives and dander/gouge scrapers; and (3) clinical specialty and accessory products including the SteriHeel Plus infant heel incision device, skin-prick allergy test needles, insulin pen needles (Easydrip Plus with Hextra Tech hub) and alcohol pads. Products are gamma-sterilized with a 5-year shelf life and sold globally under the Sterilance and Sandstone brands and via OEM/ODM supply to medical device brands such as Roche.

Product overview

Sterilance Medical (苏州施莱医疗器械有限公司) is a comprehensive medical device manufacturer founded in 1993, specializing in design, R&D, manufacturing, and sales. The company offers three main product categories: (1) Peripheral blood collection products including safety lancets (Press, Press Plus, Impress, Elite, Elite Pro, Lite3, Lite4, Flex3 models), lancing devices (LDE4), and lancet needles (Soft, SoftSure, Soft5 types); (2) Surgical instruments including sterile surgical blades, safety scalpels (Index Asurity), plastic handle scalpels, mini scalpels, stitch cutters, skin graft knives, and dander scrapers; (3) Clinical accessories including alcohol pads and infant heel incision devices (SteriHeel Plus). The portfolio also includes innovative products like NANOSense lancing device with SoftSense lancets and insulin pen needles under the Sandstone Medical sub-brand. The company serves the global market through partnerships with major blood glucose meter brands including Roche, exporting to over 50 countries.

Differentiator

Problem solved

Functional benefit

Brands

• Sandstone Medical: Diabetes care sub-brand of SteriLance Medical, developing pen needles, safety lancets, and lancing devices with a focus on human-factors engineering.

Products and services

• Press (Pressure-activated Press Model) Safety Lancet Pressure-activated safety lancet with one-step cap removal and press activation, featuring a safety-lock mechanism for single-use peripheral blood collection. Sterilized by gamma ray radiation. Targeted at clinical capillary blood sampling for blood glucose, blood typing, CBC, ESR, newborn screening, and point-of-care tests.
• Press Plus (Pressure-activated Press Plus Model) Safety Lancet Enhanced pressure-activated safety lancet with a dual-spring design and cap-removal/press activation, supporting single-hand operation for peripheral blood collection. Sterilized by gamma ray, suitable for clinical capillary blood sampling.
• Impress Series Safety Lancet Pressure-activated safety lancet series with a patented 'light touch dot' structure, three cap形态 variants, transparent compact appearance, and safety-lock mechanism for single-use peripheral blood collection.
• Elite (Button-activated Elite Model) Safety Lancet Button-activated safety lancet with tail-press activation and dual-spring design for peripheral blood collection, suitable for clinical skin puncture to collect capillary blood samples.
• Elite Pro (Adjustable Elite Pro Model) Safety Lancet Adjustable safety lancet with dual-spring design and T-type protective shoulder, featuring tail-press activation with three adjustable penetration depths (1.3/1.8/2.3mm) for peripheral blood collection.
• Lite4 (Button-activated Lite4 Model) Safety Lancet Button-activated safety lancet for single-use peripheral blood collection, featuring a side-press emission mechanism.
• Lite3 (Button-activated Lite3 Model) Safety Lancet Button-activated safety lancet with safety-lock mechanism and side-press emission for single-use peripheral blood collection.
• Flex3 (Adjustable Flex3 Model) Safety Lancet Adjustable safety lancet with three built-in penetration depths (1.3/1.8/2.3mm) that can be adjusted on-site based on patient skin thickness and peripheral blood circulation.
• LDE4 Adjustable Lancing Device Adjustable medical lancing device with 9 penetration depth settings suitable for different patient groups, used with disposable lancet needles for peripheral blood collection at home or in clinical settings.
• NANOSense & SoftSense One-Step Lancing System Cylindrical lancing device (NANOSense) with one-step needle loading without cap removal, exclusively compatible with SoftSense lancets, for safe, low-pain home blood glucose monitoring. For export only.
• Soft Lancet Needle Disposable lancet needle produced via automated production, with a triple-bevel tip design, gamma ray sterilization, and a 5-year shelf life for blood glucose monitoring.
• SoftSure Lancet Needle Disposable lancet needle compatible with the Sterilance LDE4 lancing device for peripheral blood collection, featuring a sharp needle tip and smooth faceted surface.
• Soft5 Lancet Needle (Roche Softclix-compatible) Disposable lancet needle designed exclusively for use with Roche Softclix lancing pens, manufactured as an authorized OEM product under Sterilance-Roche partnership. Available with a 5-bevel tip option for enhanced comfort.
• SteriHeel Plus Infant Heel Incision Safety Lancet Specialized infant heel incision safety lancet with an apple-shaped design, available in multiple incision depths (0.85mm-1.0mm) and lengths (1.75mm-2.5mm) to provide sufficient sample volume with minimal trauma for newborn genetic and metabolic disease screening.
• Skin Prick Test Puncture Needle Single-use sterile skin prick test needle for allergy screening, designed to simultaneously detect allergic reactions to up to 50 different substances including pollen, mold, pet dander, dust mites, and food.
• Sterile Surgical Blades Sterile surgical blades in carbon steel and stainless steel, available in various specifications (No.9#-36#, PM40#, 60#, 70#), designed for smooth incision with reduced tissue trauma in surgical procedures.
• Disposable Safety Scalpel (Index Asurity Model) Single-use safety scalpel with a top-button design for ambidextrous use and an integrated handle scale, designed to prevent cross-contamination in surgical procedures.
• Plastic Handle Scalpel (Standard I) Disposable plastic handle scalpel with an integrated blade body that eliminates manual blade loading/unloading, available in specifications No.9#-26#, designed for clinical soft tissue cutting.
• Mini I Scalpel Disposable plastic handle mini scalpel for minimally invasive procedures, available in specifications No.9#-17#, with sterile options upon customer request.
• Disposable Suture/Stitch Cutter Disposable surgical blade with a sickle-shaped design for suture removal, available in carbon steel and stainless steel, in 65mm and 110mm lengths. For export only.
• Disposable Skin Graft Knife Disposable skin graft blade for use with common grafting knife handles, specifically designed for skin graft surgery, 158mm length. For export only.
• Dander / Gouge Scraper Blade Disposable surgical blade for podiatrists treating skin conditions of the feet, used for cutting soft tissue during surgery, compatible with #3 scalpel handle.
• Alcohol Pads (Xiao Mian Bei / 晓棉贝) Alcohol pads composed of 75% medical alcohol solution and spunlace non-woven fabric, aluminum-foil-sealed for skin disinfection before injection or infusion. Sold under the Xiaomianbei (晓棉贝) brand.
• Easydrip Plus Pen Needles with Hextra Tech Hexagonal Hub Insulin pen needles featuring a hexagonal broad-platform hub (Hextra Tech) that improves injection stability and user comfort, with lower needle deformation and higher anti-tilt resistance for consistent subcutaneous insulin delivery.

Quantifiable outcome

• 470 tons of CO₂ emissions reduced per year through solar power systems and recyclable packaging
• +4 more outcomes

Named customers2 records

Segments5 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature7 records

Partnerships

Three partnerships are on record, tiered minor and core.

• University of Shanghai for Science and Technology (USST)minorStrategic or Co-development Partner · 3 November 2025Researchers at the University of Shanghai for Science and Technology conducted a peer-reviewed study on Sandstone's Easydrip Plus pen needles with Hextra Tech hexagonal hub, published in the International Journal of Biomedical Engineering and Technology. The study validated that the hexagonal hub design improves injection stability and user comfort compared to conventional needles.
• Sandstone Medical Regional Distributor (Turkey/Middle East)minorChannel Partner/ Reseller/ Distributor · 11 October 2025Sandstone Medical launched its Easydrip Plus pen needles in Turkey through a regional diabetes distributor and pharmacy network, with plans to expand into neighboring Middle Eastern markets. The product features hexagonal hub design, ISO 13485 and CE certifications.
• Roche Diabetes CarecoreOEM/ Whitelabel/ Licensing PartnerSteriLance Medical is an authorized OEM supplier of lancet needles for Roche blood glucose meters, manufacturing Soft5-type lancets compatible with Roche Softclix lancing devices. This is described as a 10+ year partnership built on mutual benefit, top-notch product quality, and strong foundation of trust. The partnership is presented as a reference customer relationship demonstrating SteriLance's OEM/ODM capabilities.

Scale indicators7 records

Recent moves9 records

Expansion highlights6 records

Direct peers

• Ypsomed: Swiss manufacturer of insulin pen needles (mylife Clickfine), injection systems, and diabetes care products. Direct competitor in pen needles and adjacent to Sterilance's Sandstone sub-brand offering.
• Improve Medical: Chinese-based manufacturer of safety lancets, blood collection devices, and pen needles. Closest geographic peer in the Chinese safety lancet category with comparable OEM/ODM business model.
• HTL-Strefa: Polish-based global manufacturer specializing in safety lancets, pen needles, and capillary blood collection devices. Direct OEM competitor in the same product category serving global blood glucose meter brands, similar business model to Sterilance.
• Owen Mumford: UK-headquartered medical device company manufacturing safety lancets, auto-injectors, and pen needles for diabetes and diagnostics. Comparable in product portfolio (capillary blood sampling, insulin delivery) and OEM/private-label customer base.
• Sarstedt: German manufacturer of capillary blood collection devices, lancets, and clinical laboratory consumables. Overlapping product lines in safety lancets and blood collection needles with Sterilance, serving hospital and laboratory channels globally.
• Greiner Bio-One: Austrian/German-headquartered manufacturer of pre-analytical blood collection products including safety lancets and capillary blood sampling devices. Direct overlap with Sterilance in capillary blood collection consumables.

Broad incumbents

• Terumo: Japanese global medical device company with overlapping capillary blood collection and injection product lines. Significantly larger and more diversified than Sterilance but with relevant comparable categories.
• Nipro: Japan-headquartered global medical device manufacturer with overlapping offerings in lancets, pen needles, and injection-related products. Broad incumbent with diversified portfolio including dialysis and hospital products.
• Smiths Medical (ICU Medical): Global medical device company (now part of ICU Medical) offering safety lancets, needles, and related capillary blood collection devices. Broad incumbent with adjacent and overlapping product categories to Sterilance.
• BD (Becton Dickinson): Global medical technology incumbent with broad portfolios in diabetes care (BD Ultra-Fine pen needles), pre-analytical systems, and safety lancets. Larger scale and broader portfolio than Sterilance, but overlapping in safety lancets and pen needles.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat7 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/SterilanceMed
• Facebookfacebook.com/people/SteriLance-Medical-Suzhou-Inc-100083324021605
• LinkedInlinkedin.com/company/sterilance-medical
• Instagraminstagram.com/sterilancemedical

Compliance9 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Subsidiaries2 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 Sterilance Medical