Sterisets International

What Sterisets International does

Sterisets International B.V. is a privately held Dutch medical device manufacturer founded in 1996 as a spin-off of a Dutch medical distribution company. The company designs, manufactures, and distributes single-use sterile medical products — including custom-made procedure packs, prefilled syringes, nitrile examination gloves, single-use steel instruments, surgical drapes, patient warming systems, and closure caps — sold under three brands: Sterisets® (core), Steriflush® (prefilled syringes and nasal sprays), and Medisp® (disposables and instruments). Its primary customers are hospitals and clinics worldwide, supplied through a B2B direct-sales motion across more than 70 countries and approximately 700 customer accounts.

The company operates a vertically integrated production model across multiple European facilities in Oss (Netherlands) and Portugal (Penafiel, Guilhufe, and three recently acquired sites in Mora, Alentejo). In-house capabilities span injection molding (up to 250,000 kg of plastic processed annually), syringe filling and inspection in an ISO 5 cleanroom, ISO 7 cleanroom assembly of procedure packs, lamination, packaging, and — following the October 2025 Medirm and Estereobato acquisition — in-house ethylene oxide (EO) sterilization. A 3,500 m² warehouse in the Netherlands supports global distribution of standard assortment products. The firm is pursuing ISO/IEC 17025 laboratory accreditation and was the first to secure an MDR certificate for prefilled 0.9% NaCl syringes.

Commercially, Sterisets generates revenue by selling physical medical devices under quote-based B2B contracts, with prices determined per customer agreement rather than publicly disclosed. The go-to-market relies on direct sales managers, MEDICA trade fair presence, and digital channels (LinkedIn, YouTube, newsletter). The company is family-owned with no disclosed external investors, no funding rounds on record, and a workforce of approximately 220 employees (200 baseline plus 20 added through the 2025 acquisition). Recent strategic priorities have centered on vertical integration through M&A, regulatory compliance (MDR, ISO 17025), ERP modernization (QAD), and selective capacity expansion rather than aggressive geographic or product diversification.

Name

Sterisets International

Legal name

Sterisets International B.V.

Website

https://sterisets.com

Company type

Private

Founded year

1996

Operating status

Operating

Headcount range

251–500 employees

Short description

Sterisets International B.V. is a Dutch private manufacturer of single-use sterile medical devices and custom procedure packs, serving hospitals and clinics in 70+ countries through vertically integrated European production under the Sterisets, Steriflush, and Medisp brands.

Ownership category

akta.pro rank

Product category

Single-Use 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), Wholesale-Medical, Dental & Hospital Equipment & Supplies (5047)

akta.pro primary industry

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

akta.pro secondary industries

Sterilization Equipment & Systems (Autoclaves, Low-Temp, ETO, H2O2, UV) (HLAHANAA), Sterilization Services & Contract Reprocessing (ETO/Gamma/E-beam providers) (HLAHANAB), Sterilization Consumables & Packaging (Wraps, Pouches, Indicators, Trays/Containers) (HLAHANAC), Sterile & Aseptic Medical Packaging (Pouches, Wraps, Sterile Barriers) (IMALAIAB), Medical & Pharmaceutical Thermoformed Packaging (IMANAHAB)

Keywords

• Single-use medical devices
• Sterile procedure packs
• Custom medical sets
• Prefilled syringes
• Medical device manufacturing

Headquarters

HQ city

Oss

HQ country

Netherlands

HQ region

Europe

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Manufacturing and Distribution: Sterisets manufactures and sells single-use medical products (custom-made sets, prefilled syringes, gloves, instruments, etc.) directly to hospitals and clinics. The company operates an in-house, high-volume production model, maintaining full control over quality and costs. Revenue is generated through the sale of physical medical products across a global distribution network spanning more than 70 countries.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Sterisets International B.V. is a Dutch medical device manufacturer that produces single-use sterile medical devices and customized procedure packs for hospitals and clinics. Its portfolio spans custom-made medical sets (catheterization, dialysis, anesthesia, eye, suture, pain, urine, and dressing), Steriflush prefilled syringes, Medisp single-use instruments, examination gloves, convective patient warming systems, drapes, wrappers, and ancillary sterile consumables. Products are manufactured in-house at three vertically integrated European production facilities (Netherlands and Portugal) and sold directly to healthcare providers in more than 70 countries.

Product overview

Sterisets International is a manufacturer of sterile medical products organized under three brands: Sterisets® (core brand for custom-made medical sets, procedure packs, prefilled syringes, and warming systems), Medisp® (sub-brand for single-use disposables including trays, bowls, gloves, instruments, laminated products, and closure caps), and Steriflush® (sub-brand for prefilled syringes and nasal sprays). The company operates with a vertically integrated production strategy across three facilities in Europe (Netherlands and Portugal), offering both custom-made sets tailored to hospital specifications and standardized sets for common procedures including catheterization, dialysis, anesthesia, eye, suture, pain, urine, and dressing procedures. With the October 2025 acquisition of Medirm and Estereobato, the company expanded to include full-range kit packing capability and in-house ethylene oxide (EO) sterilization.

Differentiator

Problem solved

Functional benefit

Brands

• Steriflush®: Pre-filled syringes and seawater nasal spray product line.
• Medisp®

Products and services

• Custom-Made Medical Sets Tailored medical procedure sets customized to each hospital's exact specifications, built from a component catalogue. Includes catheterization, dialysis, anesthesia, dressing, suture, eye procedure, urine, and pain sets. Manufactured in ISO 7 cleanroom; designed to reduce preparation time, lower waste, and minimize cross-infection risk.
• Procedure Packs Pre-configured medical procedure packs for various clinical applications, produced in-house for hospitals and clinics.
• Steriflush Prefilled Syringes Flagship Steriflush-branded pre-filled syringes (including 0.9% NaCl) produced in an ISO Class 5 cleanroom; first MDR certificate for prefilled syringes achieved in 2025.
• Catheterization Sets Standardized catheterization procedure sets produced in-house for hospital catheterization workflows.
• Dialysis Sets Standardized sets for dialysis procedures, manufactured as single-use sterile medical devices.
• Anesthesia Sets Standardized sets for anesthesia procedures, manufactured in-house as single-use sterile medical devices.
• Eye Procedure Sets Standardized sets for ophthalmic (eye) procedures, produced as sterile single-use medical devices.
• Suture Sets Standardized sets for suturing procedures, manufactured in-house as sterile single-use devices.
• Pain Procedure Sets Standardized sets for pain management procedures, produced as single-use sterile medical devices.
• Urine Sets Standardized sets for urine collection procedures, manufactured in-house as sterile single-use medical devices.
• Dressing Sets Standardized sets for wound dressing procedures, produced as sterile single-use medical devices.
• Convective Patient Warming System Convective patient warming system designed to maintain patient normothermia and prevent hypothermia during medical procedures.
• Convective Patient Warming Blankets Disposable warming blankets used with the convective patient warming system to prevent intraoperative hypothermia.
• Steriflush Seawater Nasal Spray Nasal spray product under the Steriflush brand, made from seawater for nasal hygiene; produced in Sterisets' own production facilities.
• Single-Use Medical Instruments (Sterisets) Single-use steel medical instruments including regular forceps, special forceps, foam sticks, scissors, and clamps, manufactured in a sterile environment.
• Medisp Nitrile Examination Gloves Category III nitrile examination gloves, latex-free, powder-free, AQL <1.5, compliant with EN 455, EN ISO 21420, and EN ISO 374; available in blue and black, sizes XS to XL, 240 mm length with 600% elasticity; UKCA-marked and Swiss-registered.
• Medisp Single-Use Instruments Disposable medical instruments (regular forceps, special forceps, foam sticks, scissors, clamps) made from 100% recyclable materials, manufactured in a sterile environment.
• Medisp Gloves (Multi-Material) Medical examination gloves available in nitrile, vinyl, cotton, latex, and PE materials under the Medisp brand.
• Medisp Trays & Bowls Medical trays and bowls for various clinical applications under the Medisp brand.
• Medisp Bowls, Jugs and Containers Medical bowls, jugs, and containers for healthcare settings under the Medisp brand.
• Medisp Trays for Medical Use Medical trays designed for specific procedural requirements under the Medisp brand.
• Medisp Laminated Products Laminated medical products including draw sheets and bibs, produced in-house under the Medisp brand.
• Medisp Wrappers and Drapes Surgical wrappers and drapes for sterile procedures, produced in-house under the Medisp brand.
• Medisp Maternity Pads Maternity pads for post-delivery care, produced under the Medisp brand.
• Medisp Closure Caps (Luer Lock) Medical closure caps including Luer Lock caps for syringe integrity and leakage prevention, produced in-house (16-cavity mold introduced 2025).
• Medisp Tourniquets Medical tourniquets for venipuncture and IV procedures, produced under the Medisp brand.
• Full-Range Kit Packing (Medirm capability) Comprehensive range of custom-made medical sets and packs from dressing sets to complete OR packs, acquired through the Medirm integration (October 2025), covering manufacturing through sterilization.

Quantifiable outcome

• Thousands of medical sets and procedure packs produced daily in ISO 7 cleanroom
• +2 more outcomes

Named customers1 record

Segments1 record

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature9 records

Partnerships

One partnership is on record.

• MedirmcoreStrategic or Co-development Partner · 1 October 2025Medirm, based in Mora, Portugal, was acquired by Sterisets International Group effective October 1, 2025. The acquisition brings in-house EO (ethylene oxide) sterilization capability, over 1,000 m² of medical production capacity, and expertise in full-range kit packing from manufacturing through sterilization. This represents a core strategic acquisition strengthening Sterisets' European manufacturing position and supply chain independence.

Scale indicators8 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Cardinal Health: Large US healthcare distributor and medical products manufacturer with deep exposure to hospital single-use devices, gloves, and surgical supplies — competes with Sterisets in tenders across the 70+ countries Sterisets serves.
• 3M Health Care: Diversified healthcare division with significant single-use medical device, sterilization, and surgical products exposure — a broad incumbent competing with Sterisets in procedure packs, drapes, and sterilization-adjacent products.
• Becton Dickinson (BD): Global medical technology giant with broad portfolios in prefilled syringes, injection systems, and surgical instruments — Sterisets' Steriflush prefilled syringes and single-use instruments compete in overlapping categories.

Direct peers

• Medline Industries: Largest privately held medical supplies manufacturer globally, with a deep portfolio in procedure packs, drapes, gloves, and single-use medical devices — Sterisets' most direct large-scale competitor across nearly every product category.
• Halyard (Owens & Minor): US-based manufacturer of sterilization wrap, surgical drapes, gowns, and procedure packs — direct competitor in sterile barrier packaging and custom procedure pack categories where Sterisets also operates.
• Lohmann & Rauscher: German-Austrian manufacturer of medical devices and hygiene products including surgical drapes, custom procedure sets, and disposable medical instruments — directly comparable mid-size European peer in custom procedure packs.
• Ansell: Australian-headquartered global leader in examination and surgical gloves, plus single-use protection products — directly comparable to Sterisets' Medisp nitrile examination glove line and surgical disposable portfolio.
• Paul Hartmann AG: German medical device and hygiene products manufacturer with strong presence in wound care, surgical sets, and examination gloves — a European mid-large peer with comparable procedure pack and disposable product offerings.
• Mölnlycke Health Care: Swedish manufacturer of single-use surgical products including procedure packs, surgical drapes, gowns, and wound care — directly comparable to Sterisets' custom procedure pack and Medisp drape portfolio, and a key European competitor.

Emerging players

• Winner Medical: Chinese medical consumables manufacturer expanding internationally in single-use wound care, surgical supplies, and procedure packs — represents the low-cost Asian production peer that may pressure Sterisets in price-sensitive markets.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UCnfmfdSoeHl6FsGTRks_niQ
• LinkedInlinkedin.com/company/sterisets-international-b.v.

Compliance12 records

Revenue estimate

Valuation estimate

Number of profiles

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 Sterisets International