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Barco NV

Active in EUDAMED
Also registered as Barco

Belgiumfrom SRN EUDAMED FDA SRN BE-MF-000000690

Barco NV is a medical device manufacturer based in Belgium, with 501 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (EU Class I and IIa; FDA Class II and I) and 2 FDA recalls as of 13 Nov 2026.

Devices
501
Registrations
EUDAMEDFDA
FDA recalls
21 ongoing

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 469
  • EUDAMED 361
  • FDA 510(k) 2

A device listed in two registries counts in both.

Device classes
  • EU Class I 256
  • FDA Class II 127
  • EU Class IIa 69
  • FDA Class I 46
  • EU Class A 3
Top EMDN categories
FDA recalls
Identifiers
  • EUDAMED SRN BE-MF-000000690
  • DUNS 371618773

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA establishment, FDA recalls

What Barco NV makes

Barco NV manufactures medical imaging systems focused on operating room (OR) visualization, including devices like the Nexxis OR series, which are designed for high-resolution display and integration with surgical environments. The Eonis product line appears to include advanced imaging solutions for intraoperative use, supporting real-time visualization and procedural guidance. These devices are tailored for surgical settings to enhance precision and workflow efficiency.

The company’s portfolio includes devices classified under EU regulations as Class A, Class I, and Class IIa, with all relevant products registered in the EU’s eudamed database. These classifications reflect varying levels of risk and regulatory oversight, ensuring compliance with medical device directives. Barco NV is headquartered in Belgium.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue501

Newest first, rows 1-50 of 501

Search and filter all 501 devices
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  • Barco Ref K9356981A1X

    Active Regimes: CE IVDR Registry: EUDAMED Class:A

  • Barco Ref K9356980A1X

    Active Regimes: CE IVDR Registry: EUDAMED Class:A

  • Barco Ref K9303340F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Barco Ref K9356021A2X

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Barco Ref K9303340I

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Barco Ref K9303340B

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Barco Ref K9303340

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Barco Ref K9356035A2X

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Barco MDSC-8532

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Barco MDSC-8532

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Barco MDSC-8532

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Barco MDSC-8527

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Barco MCC-300

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Barco MCC-300

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Nexxis OR Nexxis system Open recall

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Coronis Fusion 4MP (MDCC-4630) Ref K262412

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Barco Ref K9303340X

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Barco

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Barco Ref K9303340G

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Barco Ref K9303340D

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Barco Ref K93530191X

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Nio Color 8MP Ref K9300830B2X

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Barco Ref K9351301

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Barco Ref K9353013B

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Barco Ref K93530131X​

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Barco Ref K9351681

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Barco Ref K9353111

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Barco Ref K93530121X​

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Barco Ref K9307918B

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Barco Ref K9300360C2X

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Nio Color 2MP LED MDNC-2221

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Demetra Analytics Toolkit

    Withdrawn Registry: GUDID Class:II

  • Clinical review 2MP MDRC-2221 HLX

    Withdrawn Registry: GUDID Class:I

  • Nio Color 3MP LED MDNC-3321

    Withdrawn Registry: GUDID Class:II

  • Coronis 5MP Mammo MDMG-5121

    Withdrawn Registry: GUDID Class:II

  • Coronis 3MP LED MDCG-3221

    Withdrawn Registry: GUDID Class:II

  • Barco MDFC-8232

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Barco MDSC-8255

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Nio 5MP LED MDNG-5221

    Withdrawn Registry: GUDID Class:II

  • Barco Mammo Tomosynthesis MDMG-5221

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Nexxis System St Kit 2 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Nio Color 3MP MDNC-3421

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Barco MDSC-8255

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Nexxis OR Open recall

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Barco MDRC-2222

    Listed Registry: GUDID Class:I

  • Nexxis MNA-110

    Withdrawn Registry: GUDID Class:II

  • Nio 3MP LED MDNG-3220

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Nexxis MNT-120

    Withdrawn Registry: GUDID Class:II

  • Barco MNA-240 Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Barco Mdsc-8532

    Listed Registry: GUDID Class:I

Rows 1-50 of 501

Showing 1-50 of 501

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
BE-MF-000000690
DUNS number
371618773
EU VAT number
BE 0473191041
EUDAMED status
Active
EUDAMED registered name
Barco NV
Registered address
35, President Kennedypark, 8500, Kortrijk, Belgium
Phone
+3256233349
PRRC contact
Katrien Cardoen(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 26 Jan 2028

EUDAMED certificates (1)

TÜV SÜD Product Service GmbH 0123 1 certificate

  • G10 082788 0022 Active

    Quality management system EU MDR

    Issued
    27 Jan 2023
    Expires
    26 Jan 2028

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 2 recalls initiated by Barco NV, the earliest on 2015-05-28 and the most recent on 2022-07-27. By recorded status: 1 ongoing and 1 terminated. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 1
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

1 initiated before 2017

  • 2022

    • 27 Jul 2022 Z-1854-2022 Class II Ongoing installation issues Distribution: US Nationwide distribution in the states of FL, IL, NJ. Submission number: K173381

  • 2015

    • 28 May 2015 Z-0227-2016 Class II Terminated User settings were no longer on the monitor's memory after these systems were powered off and back on. Distribution: US Distribution to the states of : AZ, CA, FL, GA, IL, MA, NE, NJ, OH, OR and TX., and Internationally to Canada.

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Barco, Inc. BE

Frequently asked questions

How many devices does Barco NV have in the registry?

The registry currently lists 501 devices for Barco NV. Devices recorded under merged duplicate company entries are counted once.

Which registries list Barco NV's devices?

Among its 50 most recently registered devices, Barco NV has devices listed in EUDAMED (33 devices), FDA 510(k) (1 device) and FDA GUDID (35 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Barco NV's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Barco NV's devices are Class I, Class IIa, Class II and IVDR Class A. Each device page shows its own class and authorisation.

Are there FDA recall records for Barco NV?

FDA recall records list 2 recalls initiated by Barco NV, the most recent initiated on 27 Jul 2022. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for Barco NV?

EUDAMED lists 1 certificate for Barco NV (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 27 Jan 2023.

What are the newest devices from Barco NV in the registry?

The most recently registered devices listed for Barco NV include Barco, Barco MDSC-8532, Barco MDSC-8527 and Barco MCC-300.

Generated automatically from registry data and not verified by a human reviewer.