United States was the largest outside supplier.
What this market covers
Cameras that photograph the back of the eye to screen for diabetic eye disease, glaucoma and retinal problems. Eye clinics, hospitals and screening programmes buy them.
Typical segments
- Desktop fundus cameras
- Handheld fundus cameras
- Non-mydriatic cameras
- AI enabled retinal screening
Source: Eurostat
Why this market is moving now
- Extra-EU import value rose 55% 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.
Key figures
Each figure names the source it came from. Open the source list below to read the quoted line.
| Figure | Value | Year | Source |
|---|---|---|---|
| The EU imported €1.02 billion of products under CN code 901850 (Ophthalmic instruments and appliances, n.e.s.) from outside the EU in 2025. | 1.02 EUR billion | 2025 | Eurostat |
| Extra-EU imports of CN 901850 were up 55% in 2025 compared with 2020 (€658.1 million), calculated from Eurostat values. | +55 % since 2020 | 2025 | Eurostat |
| EU exports of CN 901850 to countries outside the EU were worth €1.40 billion in 2025. | 1.40 EUR billion | 2025 | Eurostat |
| Trade between EU member states in CN 901850 (intra-EU arrivals) came to €1.08 billion in 2025. | 1.08 EUR billion | 2025 | Eurostat |
| United States was the largest non-EU supplier of CN 901850 to the EU in 2025, with €398.6 million, or 39% of extra-EU imports. | 398.6 EUR million | 2025 | Eurostat |
| EU exports of CN 901850 to the United States were €198.2 million in 2025. | 198.2 EUR million | 2025 | Eurostat |
| The average value of extra-EU imports of CN 901850 was €144.49 per kilogram in 2025, calculated from Eurostat value and weight. | 144.49 EUR per kg | 2025 | Eurostat |
| Germany was the largest EU exporter of CN 901850 to non-EU countries in 2025, at €719.6 million. | 719.6 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 % since 2020 | 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 23 510(k) clearances for devices named "fundus camera". | 23 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| 3 of those clearances were issued from 2021 to 2025. | 3 510(k) clearances | 2025 | U.S. Food and Drug Administration |
| Canon Usa, Inc. holds 6 510(k) clearances for devices named "fundus camera". | 6 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Canon, Inc. holds 2 510(k) clearances for devices named "fundus camera". | 2 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Kowa Optimed, Inc. holds 2 510(k) clearances for devices named "fundus camera". | 2 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Nidek, Inc. holds 2 510(k) clearances for devices named "fundus camera". | 2 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| C.S.O. S.R.L. holds 1 510(k) clearances for devices named "fundus camera". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Carl Zeiss Jena Gmbh holds 1 510(k) clearances for devices named "fundus camera". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| PubMed indexed 516 papers mentioning "fundus photography" in the title or abstract in 2025. | 516 papers | 2025 | U.S. National Library of Medicine |
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)
Quoted lines
- Figure 1
DS-045409, reporter EU27_2020, product 901850, partner EXT_EU27_2020, flow import, 2025, VALUE_IN_EUROS 1022610247
- Figure 2
DS-045409, reporter EU27_2020, product 901850, flow import, 2020 VALUE_IN_EUROS 658054079; 2025 VALUE_IN_EUROS 1022610247
- Figure 3
DS-045409, reporter EU27_2020, product 901850, partner EXT_EU27_2020, flow export, 2025, VALUE_IN_EUROS 1398199397
- Figure 4
DS-045409, reporter EU27_2020, product 901850, partner INT_EU27_2020, flow import, 2025, VALUE_IN_EUROS 1078848272
- Figure 5
DS-045409, reporter EU27_2020, product 901850, partner US, flow import, 2025, VALUE_IN_EUROS 398563186
- Figure 6
DS-045409, reporter EU27_2020, product 901850, partner US, flow export, 2025, VALUE_IN_EUROS 198225843
- Figure 7
DS-045409, reporter EU27_2020, product 901850, flow import, 2025, VALUE_IN_EUROS 1022610247, QUANTITY_IN_100KG 70772
- Figure 1
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
Quoted lines
- Figure 8
DS-045409, reporter DE, product 901850, partner EXT_EU27_2020, flow export, 2025, VALUE_IN_EUROS 719599948
- Figure 8
- Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)
Quoted lines
- Figure 9
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs ENT_NR, 2023, 63227
- Figure 10
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs NETTUR_MEUR, 2021, 105308
- Figure 11
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs EMP_NR, 2023, 600000
- Figure 9
- U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 339112, 2025 (2026-11-04)
Quoted lines
- Figure 12
QCEW 2025 annual, US000, private, NAICS 339112, annual_avg_estabs 4547
- Figure 13
QCEW 2025 annual, US000, private, NAICS 339112, annual_avg_emplvl 140413
- Figure 14
QCEW 2020 annual_avg_emplvl 135655; 2025 annual_avg_emplvl 140413
- Figure 15
QCEW 2025 annual, US000, private, NAICS 339112, avg_annual_pay 109475
- Figure 12
- U.S. Food and Drug Administration: openFDA 510(k) clearances, device_name "fundus camera" (2026-11-04)
Quoted lines
- Figure 16
openFDA device/510k device_name:"fundus camera", sum of counts by decision_date = 23
- Figure 17
openFDA device/510k decision_date 2021-2025 count = 3
- Figure 16
- U.S. Food and Drug Administration: openFDA 510(k) clearances by applicant, device_name "fundus camera" (2026-11-04)
Quoted lines
- Figure 18
applicant.exact "Canon USA, Inc." count 6
- Figure 19
applicant.exact "Canon, Inc." count 2
- Figure 20
applicant.exact "Kowa Optimed, Inc." count 2
- Figure 21
applicant.exact "Nidek, Inc." count 2
- Figure 22
applicant.exact "C.S.O. S.R.L." count 1
- Figure 23
applicant.exact "Carl Zeiss Jena GmbH" count 1
- Figure 18
- U.S. National Library of Medicine: PubMed search "fundus photography"[tiab] AND 2025[dp] (2026-11-04)
Quoted lines
- Figure 24
esearch count 516
- Figure 24
Buyers and suppliers
Who buys
- Eye clinics
- Hospitals
- Screening programmes
Large non-EU suppliers to the EU
Companies to watch
Canon Usa, Inc.
6 FDA 510(k) clearances for devices named "fundus camera".
Canon, Inc.
2 FDA 510(k) clearances for devices named "fundus camera".
Kowa Optimed, Inc.
2 FDA 510(k) clearances for devices named "fundus camera".
Nidek, Inc.
2 FDA 510(k) clearances for devices named "fundus camera".
C.S.O. S.R.L.
1 FDA 510(k) clearances for devices named "fundus camera".
Carl Zeiss Jena Gmbh
1 FDA 510(k) clearances for devices named "fundus camera".
What the full report covers
- 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
- Ready-to-use charts
- Method note and assumptions
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Frequently asked questions
How big is the EU fundus camera market?
There is no single official market total. Eurostat trade data shows the EU imported €1.02 billion of goods under CN 901850 from outside the EU in 2025 and exported €1.40 billion.
Where does the EU import fundus camera from?
United States was the largest non-EU supplier in 2025. Other large suppliers included Switzerland, Japan, United Kingdom.
What is the average import price of fundus camera in the EU?
Dividing Eurostat import value by weight gives about €144.49 per kilogram for CN 901850 in 2025.
Which EU countries export the most fundus camera?
Germany led EU exports to non-EU countries in 2025, followed by Netherlands, Belgium.
How many fundus camera devices are cleared by the FDA?
openFDA lists 23 510(k) clearances for devices named fundus camera.
Which companies hold the most FDA clearances for fundus camera?
By 510(k) count: Canon Usa, Inc., Canon, Inc., Kowa Optimed, Inc., Nidek, Inc..
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