-13 % change
Extra-EU imports of CN 84192000 were down 13% in 2025 compared with 2020 (€78.7 million), calculated from Eurostat values.
Eurostat368.7 EUR million
EU exports of CN 84192000 to countries outside the EU were worth €368.7 million in 2025.
Eurostat220.9 EUR million
Trade between EU member states in CN 84192000 (intra-EU arrivals) came to €220.9 million in 2025.
EurostatSource: Eurostat
Why this market is moving now
- Extra-EU import value moved -13% from 2020 to 2025, a direct read on EU demand for sourced supply.
- Supply is concentrated: one country provided a large share of extra-EU imports in 2025.
- US employment in the core industry shifted +4% since 2020.
What this market covers
Machines that wash and thermally disinfect surgical tools and reusable medical items. Hospital sterile processing departments use them before sterilization.
Typical segments
- Instrument washers
- Utensil washers
- Cart washers
- Ultrasonic cleaning units
Who buys
- Hospitals
- Surgery centres
- Dental clinics
Largest non-EU suppliers to the EU
| Country | Import value |
|---|---|
| United States from 1995 -> 2000) | 17.4 EUR million |
| China | 16.9 EUR million |
| Switzerland | 15.4 EUR million |
| United Kingdom | 4.1 EUR million |
| Mexico | 3.6 EUR million |
| Türkiye | 2.8 EUR million |
Key figures
Each figure links to the page it came from.
| Figure | Value | Year | Source |
|---|---|---|---|
| The EU imported €68.3 million of products under CN code 84192000 (Medical, surgical or laboratory sterilizers) from outside the EU in 2025. | 68.3 EUR million | 2025 | Eurostat |
| Extra-EU imports of CN 84192000 were down 13% in 2025 compared with 2020 (€78.7 million), calculated from Eurostat values. | -13 % change | 2025 | Eurostat |
| EU exports of CN 84192000 to countries outside the EU were worth €368.7 million in 2025. | 368.7 EUR million | 2025 | Eurostat |
| Trade between EU member states in CN 84192000 (intra-EU arrivals) came to €220.9 million in 2025. | 220.9 EUR million | 2025 | Eurostat |
| United States from 1995 -> 2000) was the largest non-EU supplier of CN 84192000 to the EU in 2025, with €17.4 million, or 26% of extra-EU imports. | 17.4 EUR million | 2025 | Eurostat |
| EU exports of CN 84192000 to the United States were €65.6 million in 2025. | 65.6 EUR million | 2025 | Eurostat |
| The average value of extra-EU imports of CN 84192000 was €36.19 per kilogram in 2025, calculated from Eurostat value and weight. | 36.19 EUR per kg | 2025 | Eurostat |
| Italy was the largest EU exporter of CN 84192000 to non-EU countries in 2025, at €123.3 million. | 123.3 EUR million | 2025 | Eurostat |
| The EU had 63,227 enterprises in NACE class C3250 (Manufacture of medical and dental instruments and supplies) in 2023. | 63,227 enterprises | 2023 | Eurostat |
| EU enterprises in NACE class C3250 had net turnover of €105.31 billion in 2021. | 105.31 EUR billion | 2021 | Eurostat |
| NACE class C3250 employed 600,000 people across the EU in 2023. | 600,000 persons employed | 2023 | Eurostat |
| The US had 4,547 private establishments in NAICS 339112 (Surgical and medical instrument manufacturing) in 2025. | 4,547 establishments | 2025 | U.S. Bureau of Labor Statistics |
| NAICS 339112 employed an average of 140,413 people in US private industry in 2025. | 140,413 jobs | 2025 | U.S. Bureau of Labor Statistics |
| US employment in NAICS 339112 changed by +4% between 2020 (135,655 jobs) and 2025, calculated from BLS figures. | +4 % change | 2025 | U.S. Bureau of Labor Statistics |
| Average annual pay in US NAICS 339112 was $109,475 in 2025. | 109,475 USD per year | 2025 | U.S. Bureau of Labor Statistics |
| The FDA has recorded 10 510(k) clearances for devices named "washer disinfector". | 10 510(k) clearances | 2026 | U.S. Food and Drug Administration (openFDA) |
| 3 of those clearances were issued from 2021 to 2025. | 3 510(k) clearances | 2025 | U.S. Food and Drug Administration (openFDA) |
| Steris Corporation holds 3 510(k) clearances for devices named "washer disinfector". | 3 510(k) clearances | 2026 | U.S. Food and Drug Administration (openFDA) |
| Steris holds 2 510(k) clearances for devices named "washer disinfector". | 2 510(k) clearances | 2026 | U.S. Food and Drug Administration (openFDA) |
| Custom Ultrasonics holds 1 510(k) clearances for devices named "washer disinfector". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration (openFDA) |
| Custom Ultrasonics, Inc. holds 1 510(k) clearances for devices named "washer disinfector". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration (openFDA) |
| Mdt Biologic Co. holds 1 510(k) clearances for devices named "washer disinfector". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration (openFDA) |
| Miele Appliances, Inc. holds 1 510(k) clearances for devices named "washer disinfector". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration (openFDA) |
| PubMed indexed 7 papers mentioning "washer disinfector" in the title or abstract in 2025. | 7 papers | 2025 | U.S. National Library of Medicine (PubMed) |
Companies to watch
Steris Corporation
3 FDA 510(k) clearances for devices named "washer disinfector".
Steris
2 FDA 510(k) clearances for devices named "washer disinfector".
Custom Ultrasonics
1 FDA 510(k) clearances for devices named "washer disinfector".
Custom Ultrasonics, Inc.
1 FDA 510(k) clearances for devices named "washer disinfector".
Mdt Biologic Co.
1 FDA 510(k) clearances for devices named "washer disinfector".
Miele Appliances, Inc.
1 FDA 510(k) clearances for devices named "washer disinfector".
What the full report covers
- 1
Executive summary
The answer on two pages: size, growth and what drives it.
- 2
Market size and outlook
History, the current year and a five-year view with base, low and high cases.
- 3
Segments and regions
Splits by product, buyer and geography across the US, Europe and MEA.
- 4
Company profiles
The main players, how they compete and where they are investing.
- 5
Data and method
Every figure in Excel, with the sources and assumptions behind it.
- 01Executive summary
The answer in one page: size, direction and what moves it - 02Market definition and scope
What is in and out of the European Union market - 03Market size, 2021 to 2025
Historical series and growth rates - 04Outlook to 2031
Base, low and high scenarios with stated assumptions - 05Rules, policy and deadlines
Regulation and programmes that change demand - 06Drivers and barriers
What accelerates or slows adoption, by customer segment - 07Prices, costs and margins
Unit economics where public data allows - 08Competitive landscape
8 to 12 company profiles with recent moves - 09Opportunities and risks
For new entrants, suppliers and investors - 10Method and sources
Every assumption and source, listed
Included with the full report
- PDF report, 40 to 60 pages
- Excel data pack
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- Method note and assumptions
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Frequently asked questions
How big is the EU automated medical washer disinfector market?
There is no single official market total. Eurostat trade data shows the EU imported €68.3 million of goods under CN 84192000 from outside the EU in 2025 and exported €368.7 million.
Where does the EU import automated medical washer disinfector from?
United States from 1995 -> 2000) was the largest non-EU supplier in 2025. The next largest were China, Switzerland, United Kingdom.
What is the average import price of automated medical washer disinfector in the EU?
Dividing Eurostat import value by weight gives about €36.19 per kilogram for CN 84192000 in 2025.
Which EU countries export the most automated medical washer disinfector?
Italy led EU exports to non-EU countries in 2025, followed by Germany, Poland.
How many automated medical washer disinfector devices are cleared by the FDA?
openFDA lists 10 510(k) clearances for devices named washer disinfector.
Which companies hold the most FDA clearances for automated medical washer disinfector?
By 510(k) count: Steris Corporation, Steris, Custom Ultrasonics, Custom Ultrasonics, Inc..
Sources and method
The figures on this page come from the public sources listed below. Read how we work.
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
DS-045409, reporter EU27_2020, product 84192000, partner EXT_EU27_2020, flow import, 2025, VALUE_IN_EUROS 68255434
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
DS-045409, reporter EU27_2020, product 84192000, flow import, 2020 VALUE_IN_EUROS 78740236; 2025 VALUE_IN_EUROS 68255434
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
DS-045409, reporter EU27_2020, product 84192000, partner EXT_EU27_2020, flow export, 2025, VALUE_IN_EUROS 368742724
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
DS-045409, reporter EU27_2020, product 84192000, partner INT_EU27_2020, flow import, 2025, VALUE_IN_EUROS 220926079
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
DS-045409, reporter EU27_2020, product 84192000, partner US, flow import, 2025, VALUE_IN_EUROS 17429699
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
DS-045409, reporter EU27_2020, product 84192000, partner US, flow export, 2025, VALUE_IN_EUROS 65600294
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
DS-045409, reporter EU27_2020, product 84192000, flow import, 2025, VALUE_IN_EUROS 68255434, QUANTITY_IN_100KG 18863
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
DS-045409, reporter IT, product 84192000, partner EXT_EU27_2020, flow export, 2025, VALUE_IN_EUROS 123343922
- Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs ENT_NR, 2023, 63227
- Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs NETTUR_MEUR, 2021, 105308
- Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs EMP_NR, 2023, 600000
- U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 339112, 2025 (2026-11-04)
QCEW 2025 annual, US000, private, NAICS 339112, annual_avg_estabs 4547
- U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 339112, 2025 (2026-11-04)
QCEW 2025 annual, US000, private, NAICS 339112, annual_avg_emplvl 140413
- U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 339112, 2025 (2026-11-04)
QCEW 2020 annual_avg_emplvl 135655; 2025 annual_avg_emplvl 140413
- U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 339112, 2025 (2026-11-04)
QCEW 2025 annual, US000, private, NAICS 339112, avg_annual_pay 109475
- U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances, device_name "washer disinfector" (2026-11-04)
openFDA device/510k device_name:"washer disinfector", sum of counts by decision_date = 10
- U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances, device_name "washer disinfector" (2026-11-04)
openFDA device/510k decision_date 2021-2025 count = 3
- U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "washer disinfector" (2026-11-04)
applicant.exact "STERIS Corporation" count 3
- U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "washer disinfector" (2026-11-04)
applicant.exact "Steris" count 2
- U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "washer disinfector" (2026-11-04)
applicant.exact "Custom Ultrasonics" count 1
- U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "washer disinfector" (2026-11-04)
applicant.exact "Custom Ultrasonics, Inc." count 1
- U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "washer disinfector" (2026-11-04)
applicant.exact "Mdt Biologic Co." count 1
- U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "washer disinfector" (2026-11-04)
applicant.exact "Miele Appliances, Inc." count 1
- U.S. National Library of Medicine (PubMed): PubMed search "washer disinfector"[tiab] AND 2025[dp] (2026-11-04)
esearch count 7
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