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Healthcare & Life SciencesEuropean UnionUpdated 4 Nov 2026

Pediatric medical devices Market 2026: trade data and key figures

The EU imported €8.07 billion of pediatric medical devices and related goods (CN 90189084) from outside the EU in 2025. That was 43% more than in 2020. United States was the largest outside supplier.

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Region
European Union
Evidence
24 sourced figures from 7 sources
Last checked
4 Nov 2026
Extra-EU imports of CN 90189084, EUR million20202025

8.07EUR billion

EU imports from outside the EU, 2025

+43% change

Extra-EU imports of CN 90189084 were up 43% in 2025 compared with 2020 (€5.66 billion), calculated from Eurostat values.

10.98EUR billion

EU exports of CN 90189084 to countries outside the EU were worth €10.98 billion in 2025.

10.33EUR billion

Trade between EU member states in CN 90189084 (intra-EU arrivals) came to €10.33 billion in 2025.

OverviewDataBuyers and suppliersWhat is insideFAQ

What this market covers

Pediatric medical devices are instruments and implants sized and designed for infants, children and teenagers. Buyers are children's hospitals, clinics and paediatric specialists.

Typical segments

  • Pediatric monitoring devices
  • Pediatric respiratory devices
  • Pediatric orthopaedic devices
  • Pediatric surgical instruments
ChartExtra-EU imports of CN 90189084, EUR million
Extra-EU imports of CN 90189084, EUR million02,5005,0007,50010k2020: 5,661 EUR million5,66120202021: 6,035 EUR million20212022: 7,020 EUR million20222023: 7,567 EUR million20232024: 7,809 EUR million20242025: 8,074 EUR million8,0742025

Source: Eurostat

Why this market is moving now

  • Extra-EU import value moved +43% 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.

Key figures

Each figure names the source it came from. Open the source list below to read the quoted line.

FigureValueYearSource
The EU imported €8.07 billion of products under CN code 90189084 (Instruments and appliances used in medical, surgical or veterinary sciences, n.e.s.) from outside the EU in 2025.8.07 EUR billion2025Eurostat
Extra-EU imports of CN 90189084 were up 43% in 2025 compared with 2020 (€5.66 billion), calculated from Eurostat values.+43 % change2025Eurostat
EU exports of CN 90189084 to countries outside the EU were worth €10.98 billion in 2025.10.98 EUR billion2025Eurostat
Trade between EU member states in CN 90189084 (intra-EU arrivals) came to €10.33 billion in 2025.10.33 EUR billion2025Eurostat
United States was the largest non-EU supplier of CN 90189084 to the EU in 2025, with €3.40 billion, or 42% of extra-EU imports.3.40 EUR billion2025Eurostat
EU exports of CN 90189084 to the United States were €4.19 billion in 2025.4.19 EUR billion2025Eurostat
The average value of extra-EU imports of CN 90189084 was €110.31 per kilogram in 2025, calculated from Eurostat value and weight.110.31 EUR per kg2025Eurostat
Netherlands was the largest EU exporter of CN 90189084 to non-EU countries in 2025, at €2.85 billion.2.85 EUR billion2025Eurostat
The EU had 63,227 enterprises in NACE class C3250 (Manufacture of medical and dental instruments and supplies) in 2023.63,227 enterprises2023Eurostat
EU enterprises in NACE class C3250 had net turnover of €105.31 billion in 2021.105.31 EUR billion2021Eurostat
NACE class C3250 employed 600,000 people across the EU in 2023.600,000 persons employed2023Eurostat
The US had 4,547 private establishments in NAICS 339112 (Surgical and medical instrument manufacturing) in 2025.4,547 establishments2025U.S. Bureau of Labor Statistics
NAICS 339112 employed an average of 140,413 people in US private industry in 2025.140,413 jobs2025U.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 % change2025U.S. Bureau of Labor Statistics
Average annual pay in US NAICS 339112 was $109,475 in 2025.109,475 USD per year2025U.S. Bureau of Labor Statistics
The FDA has recorded 445 510(k) clearances for devices named "pediatric".445 510(k) clearances2026U.S. Food and Drug Administration
25 of those clearances were issued from 2021 to 2025.25 510(k) clearances2025U.S. Food and Drug Administration
Karl Storz Endoscopy-America, Inc. holds 9 510(k) clearances for devices named "pediatric".9 510(k) clearances2026U.S. Food and Drug Administration
Orthopediatrics Corp. holds 7 510(k) clearances for devices named "pediatric".7 510(k) clearances2026U.S. Food and Drug Administration
Covidien holds 6 510(k) clearances for devices named "pediatric".6 510(k) clearances2026U.S. Food and Drug Administration
Kendall Healthcare Products Co. Div.Of Tyco Health holds 6 510(k) clearances for devices named "pediatric".6 510(k) clearances2026U.S. Food and Drug Administration
Sigma Medical, Inc. holds 6 510(k) clearances for devices named "pediatric".6 510(k) clearances2026U.S. Food and Drug Administration
Airlife, Inc. holds 5 510(k) clearances for devices named "pediatric".5 510(k) clearances2026U.S. Food and Drug Administration
PubMed indexed 6 papers mentioning "pediatric medical devices" in the title or abstract in 2025.6 papers2025U.S. National Library of Medicine

Sources and method

The figures on this page come from the public sources listed below. Read how we work.

  1. Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
    Quoted lines
    • Figure 1DS-045409, reporter EU27_2020, product 90189084, partner EXT_EU27_2020, flow import, 2025, VALUE_IN_EUROS 8073606827
    • Figure 2DS-045409, reporter EU27_2020, product 90189084, flow import, 2020 VALUE_IN_EUROS 5660947303; 2025 VALUE_IN_EUROS 8073606827
    • Figure 3DS-045409, reporter EU27_2020, product 90189084, partner EXT_EU27_2020, flow export, 2025, VALUE_IN_EUROS 10980649367
    • Figure 4DS-045409, reporter EU27_2020, product 90189084, partner INT_EU27_2020, flow import, 2025, VALUE_IN_EUROS 10332987206
    • Figure 5DS-045409, reporter EU27_2020, product 90189084, partner US, flow import, 2025, VALUE_IN_EUROS 3396520553
    • Figure 6DS-045409, reporter EU27_2020, product 90189084, partner US, flow export, 2025, VALUE_IN_EUROS 4189259693
    • Figure 7DS-045409, reporter EU27_2020, product 90189084, flow import, 2025, VALUE_IN_EUROS 8073606827, QUANTITY_IN_100KG 731880
  2. Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
    Quoted lines
    • Figure 8DS-045409, reporter NL, product 90189084, partner EXT_EU27_2020, flow export, 2025, VALUE_IN_EUROS 2848584412
  3. Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)
    Quoted lines
    • Figure 9sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs ENT_NR, 2023, 63227
    • Figure 10sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs NETTUR_MEUR, 2021, 105308
    • Figure 11sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs EMP_NR, 2023, 600000
  4. U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 339112, 2025 (2026-11-04)
    Quoted lines
    • Figure 12QCEW 2025 annual, US000, private, NAICS 339112, annual_avg_estabs 4547
    • Figure 13QCEW 2025 annual, US000, private, NAICS 339112, annual_avg_emplvl 140413
    • Figure 14QCEW 2020 annual_avg_emplvl 135655; 2025 annual_avg_emplvl 140413
    • Figure 15QCEW 2025 annual, US000, private, NAICS 339112, avg_annual_pay 109475
  5. U.S. Food and Drug Administration: openFDA 510(k) clearances, device_name "pediatric" (2026-11-04)
    Quoted lines
    • Figure 16openFDA device/510k device_name:"pediatric", sum of counts by decision_date = 445
    • Figure 17openFDA device/510k decision_date 2021-2025 count = 25
  6. U.S. Food and Drug Administration: openFDA 510(k) clearances by applicant, device_name "pediatric" (2026-11-04)
    Quoted lines
    • Figure 18applicant.exact "KARL STORZ Endoscopy-America, Inc." count 9
    • Figure 19applicant.exact "OrthoPediatrics Corp." count 7
    • Figure 20applicant.exact "Covidien" count 6
    • Figure 21applicant.exact "Kendall Healthcare Products Co. Div.Of Tyco Health" count 6
    • Figure 22applicant.exact "Sigma Medical, Inc." count 6
    • Figure 23applicant.exact "Airlife, Inc." count 5
  7. U.S. National Library of Medicine: PubMed search "pediatric medical devices"[tiab] AND 2025[dp] (2026-11-04)
    Quoted lines
    • Figure 24esearch count 6

Buyers and suppliers

Who buys

  • Children's hospitals
  • Paediatric clinics
  • General hospitals

Large non-EU suppliers to the EU

  1. United States3,396.5 EUR million
  2. Mexico905.4 EUR million
  3. China743.0 EUR million
  4. Costa Rica604.4 EUR million
  5. Switzerland505.7 EUR million
  6. United Kingdom438.8 EUR million

Companies to watch

Karl Storz Endoscopy-America, Inc.

9 FDA 510(k) clearances for devices named "pediatric".

Orthopediatrics Corp.

7 FDA 510(k) clearances for devices named "pediatric".

Covidien

6 FDA 510(k) clearances for devices named "pediatric".

Kendall Healthcare Products Co. Div.Of Tyco Health

6 FDA 510(k) clearances for devices named "pediatric".

Sigma Medical, Inc.

6 FDA 510(k) clearances for devices named "pediatric".

Airlife, Inc.

5 FDA 510(k) clearances for devices named "pediatric".

What the full report covers

  1. 01Executive summary
    The answer in one page: size, direction and what moves it
  2. 02Market definition and scope
    What is in and out of the European Union market
  3. 03Market size, 2021 to 2025
    Historical series and growth rates
  4. 04Outlook to 2031
    Base, low and high scenarios with stated assumptions
  5. 05Rules, policy and deadlines
    Regulation and programmes that change demand
  6. 06Drivers and barriers
    What accelerates or slows adoption, by customer segment
  7. 07Prices, costs and margins
    Unit economics where public data allows
  8. 08Competitive landscape
    8 to 12 company profiles with recent moves
  9. 09Opportunities and risks
    For new entrants, suppliers and investors
  10. 10Method and sources
    Every assumption and source, listed

Included with the full report

  • PDF report, 40 to 60 pages
  • Excel data pack
  • Ready-to-use charts
  • Method note and assumptions
  • Written to order in 5 working days
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Frequently asked questions

How big is the EU pediatric medical devices market?

There is no single official market total. Eurostat trade data shows the EU imported €8.07 billion of goods under CN 90189084 from outside the EU in 2025 and exported €10.98 billion.

Where does the EU import pediatric medical devices from?

United States was the largest non-EU supplier in 2025. Other large suppliers included Mexico, China, Costa Rica.

What is the average import price of pediatric medical devices in the EU?

Dividing Eurostat import value by weight gives about €110.31 per kilogram for CN 90189084 in 2025.

Which EU countries export the most pediatric medical devices?

Netherlands led EU exports to non-EU countries in 2025, followed by Germany, Ireland.

How many pediatric medical devices devices are cleared by the FDA?

openFDA lists 445 510(k) clearances for devices named pediatric.

Which companies hold the most FDA clearances for pediatric medical devices?

By 510(k) count: Karl Storz Endoscopy-America, Inc., Orthopediatrics Corp., Covidien, Kendall Healthcare Products Co. Div.Of Tyco Health.

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