# Heuron Co., Ltd.

> Medical device manufacturer record on deviCERTS, compiled from public registries. Heuron Co., Ltd. is a medical device manufacturer based in South Korea, with 9 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II; EU Class IIa) as of 15 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/heuron-co-ltd>
- Country: South Korea (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED, FDA
- EUDAMED SRN: KR-MF-000008614
- FDA FEI: 3016727312
- DUNS: 694971646

## Figures

- Devices: 9
- 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 5, FDA 510(k) 4, EUDAMED 2
- Device classes: FDA Class II 7, EU Class IIa 2
- EMDN [Z11 Bioimaging and radiotherapy instruments](https://devicerts.com/categories/emdn/Z11): 2 devices

## Sites and related companies

- Authorised representative: [KTR Europe GmbH](https://devicerts.com/representatives/ktr-europe-gmbh-de-ar-000005685) (Germany)

## Devices

The first 9 of 9, in the order of the canonical page, which lists them all.

- [Veuron-Brain-mN1 V-B-mN1-01](https://devicerts.com/devices/veuron-brain-mn1-v-b-mn1-01) · Class II · GUDID · status: Listed
- [Veuron-Brain-pAb3 AD-AWC03](https://devicerts.com/devices/veuron-brain-pab3-ad-awc03) · Class II · GUDID · status: Active
- [Heuron ICH ST-ICT01](https://devicerts.com/devices/heuron-ich-st-ict01) · Class II · GUDID · status: Active
- [Veuron-Brain-pAb2](https://devicerts.com/devices/veuron-brain-pab2-llz) · ref K213801 · Class II · 510(k), GUDID · status: Active · decision 2022-02-04
- [Veuron-Brain-mN1](https://devicerts.com/devices/veuron-brain-mn1-lnh) · ref K203279 · Class II · 510(k) · status: Active · decision 2022-07-12
- [Veuron-Brain-pAb3](https://devicerts.com/devices/veuron-brain-pab3-llz) · ref K231642 · Class II · 510(k) · status: Active · decision 2023-10-13
- [Heuron ICH](https://devicerts.com/devices/heuron-ich-qas) · ref K233247 · Class II · 510(k) · status: Active · decision 2024-05-15
- [Veuron-Brain-pAb](https://devicerts.com/devices/veuron-brain-pab-v-b-pab-01) · ref V-B-pAb-01 · Class IIa · EUDAMED, GUDID · status: Active
- [Heuron IPD](https://devicerts.com/devices/heuron-ipd-h-pd-d05) · ref H-PD-D05 · Class IIa · EUDAMED · status: Active

## Source and citation

- Cite as: Heuron Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/heuron-co-ltd (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/), [FDA registration and listing](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm)
- 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/heuron-co-ltd.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/heuron-co-ltd
- 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.