# icometrix NV

> Medical device manufacturer record on deviCERTS, compiled from public registries. icometrix NV is a medical device manufacturer based in Belgium, with 27 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU Class IIa) as of 15 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/icometrix-nv>
- Registered in EUDAMED as: icometrix
- Country: Belgium (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer, Part of a group
- Registrations: EUDAMED
- EUDAMED SRN: BE-MF-000006329
- DUNS: 400793486

## Figures

- Devices: 27
- EU certificates: 1
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA GUDID 17, EUDAMED 7, FDA 510(k) 3
- Device classes: FDA Class II 17, EU Class IIa 7, FDA Class I 3
- EMDN [V92 Medical device software - not included in other classes](https://devicerts.com/categories/emdn/V92): 7 devices

## Sites and related companies

- Part of [icometrix](https://devicerts.com/manufacturers/icometrix)

## Devices

The first 27 of 27, in the order of the canonical page, which lists them all.

- [icobrain ctp 1.7](https://devicerts.com/devices/icobrain-ctp-1-7) · Class II · GUDID · status: Active
- [icobrain aria 1.2](https://devicerts.com/devices/icobrain-aria-1-2) · Class II · GUDID · status: Active
- [icompanion 1](https://devicerts.com/devices/icompanion-1) · Class I · GUDID · status: Listed
- [icobrain ct 6.4](https://devicerts.com/devices/icobrain-ct-6-4) · Class II · GUDID · status: Listed
- [icobrain 6](https://devicerts.com/devices/icobrain-6) · Class II · GUDID · status: Active
- [icobrain mr 5.17](https://devicerts.com/devices/icobrain-mr-5-17) · Class II · GUDID · status: Listed
- [icobrain 4.0](https://devicerts.com/devices/icobrain-4-0) · Class II · GUDID · status: Listed
- [icobrain mr 5.14](https://devicerts.com/devices/icobrain-mr-5-14) · Class II · GUDID · status: Listed
- [icobrain ctp 1](https://devicerts.com/devices/icobrain-ctp-1) · Class II · GUDID · status: Active
- [icompanion 2.2](https://devicerts.com/devices/icompanion-2-2) · Class I · GUDID · status: Listed
- [icobrain mr 5.15](https://devicerts.com/devices/icobrain-mr-5-15) · Class II · GUDID · status: Listed
- [icobrain 3](https://devicerts.com/devices/icobrain-3) · Class II · GUDID · status: Active
- [icompanion 2.1](https://devicerts.com/devices/icompanion-2-1) · Class I · GUDID · status: Active
- [icobrain aria 1.1](https://devicerts.com/devices/icobrain-aria-1-1) · Class II · GUDID · status: Active
- [icobrain 5](https://devicerts.com/devices/icobrain-5) · Class II · GUDID · status: Listed
- [icobrain 2](https://devicerts.com/devices/icobrain-2) · Class II · GUDID · status: Active
- [icobrain mr 5.16](https://devicerts.com/devices/icobrain-mr-5-16) · Class II · GUDID · status: Active
- [icobrain mr](https://devicerts.com/devices/icobrain-mr-5-16-z) · ref 5.16.z · Class IIa · EUDAMED · status: Active
- [icobrain aria](https://devicerts.com/devices/icobrain-aria-qbs) · ref K240712 · Class II · 510(k) · status: Active · decision 2024-11-07
- [Icobrain](https://devicerts.com/devices/icobrain-llz-k192130) · ref K192130 · Class II · 510(k) · status: Active · decision 2019-12-13
- [icobrain](https://devicerts.com/devices/icobrain-llz) · ref K181939 · Class II · 510(k) · status: Active · decision 2018-11-06
- [icobrain mr](https://devicerts.com/devices/icobrain-mr-5-15-z) · ref 5.15.z · Class IIa · EUDAMED · status: Active
- [icobrain ct](https://devicerts.com/devices/icobrain-ct-6-4-z) · ref 6.4.z · Class IIa · EUDAMED · status: Active
- [icompanion](https://devicerts.com/devices/icompanion-2-2-z) · ref 2.2.z · Class IIa · EUDAMED · status: Active
- [icobrain mr](https://devicerts.com/devices/icobrain-mr-6-16-z) · ref 6.16.z · Class IIa · EUDAMED · status: Active
- [icobrain ctp](https://devicerts.com/devices/icobrain-ctp-1-7-z) · ref 1.7.z · Class IIa · EUDAMED · status: Active
- [icobrain mr](https://devicerts.com/devices/icobrain-mr-5-17-z) · ref 5.17.z · Class IIa · EUDAMED · status: Active

## EU certificates

- BE23/00000345 · Quality management system · MDR · notified body SGS Belgium NV · issued 2023-12-11 · expires 2028-12-11 · status: supplemented

## Source and citation

- Cite as: icometrix NV. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/icometrix-nv (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/icometrix-nv.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/icometrix-nv
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.