# Lunit Inc.

> Medical device manufacturer record on deviCERTS, compiled from public registries. Lunit Inc. is a medical device manufacturer based in South Korea, with 11 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (FDA Class II; EU Class IIa) as of 15 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/lunit-inc>
- Country: South Korea (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED, FDA
- EUDAMED SRN: KR-MF-000005200
- FDA FEI: 3021230777
- DUNS: 690102406

## Figures

- Devices: 11
- 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: EUDAMED 5, FDA GUDID 5, FDA 510(k) 4
- Device classes: FDA Class II 6, EU Class IIa 5
- EMDN [Z11 Bioimaging and radiotherapy instruments](https://devicerts.com/categories/emdn/Z11): 5 devices

## Sites and related companies

- Authorised representative: [Obelis S.A.](https://devicerts.com/representatives/obelis-sa-be-ar-000000106) (Belgium)

## Devices

The first 11 of 11, in the order of the canonical page, which lists them all.

- [Lunit INSIGHT CXR Triage 1.0](https://devicerts.com/devices/lunit-insight-cxr-triage-1-0-bb1af085) · Class II · GUDID · status: Active
- [Lunit INSIGHT CXR Triage 1.0](https://devicerts.com/devices/lunit-insight-cxr-triage-1-0) · Class II · GUDID · status: Active
- [Lunit INSIGHT MMG (v1.1.10)](https://devicerts.com/devices/lunit-insight-mmg-v1-1-10-qdq) · ref K260320 · Class II · 510(k) · status: Active · decision 2026-04-23
- [Lunit INSIGHT DBT (V1.2)](https://devicerts.com/devices/lunit-insight-dbt-v1-2-qdq) · ref K253796 · Class II · 510(k) · status: Active · decision 2026-03-26
- [Lunit INSIGHT CXR Triage](https://devicerts.com/devices/lunit-insight-cxr-triage-qfm) · ref K211733 · Class II · 510(k) · status: No data · decision 2021-11-10
- [Lunit INSIGHT DBT v1.1](https://devicerts.com/devices/lunit-insight-dbt-v1-1-qdq) · ref K242652 · Class II · 510(k) · status: Active · decision 2024-10-04
- [Lunit INSIGHT MMG](https://devicerts.com/devices/lunit-insight-mmg-124012) · ref 124012 · Class IIa · EUDAMED, GUDID · status: Active
- [Lunit INSIGHT CXR](https://devicerts.com/devices/lunit-insight-cxr-113212) · ref 113212 · Class IIa · EUDAMED · status: Active
- [Lunit INSIGHT CXR](https://devicerts.com/devices/lunit-insight-cxr-113012) · ref 113012 · Class IIa · EUDAMED · status: Active · decision 2021-11-10
- [Lunit INSIGHT DBT](https://devicerts.com/devices/lunit-insight-dbt-126012-ae1ef5a0) · ref 126012 · Class IIa · EUDAMED, GUDID · status: Active
- [Lunit INSIGHT DBT](https://devicerts.com/devices/lunit-insight-dbt-126012) · ref 126012 · Class IIa · EUDAMED, GUDID · status: Active

## EU certificates

- MDR 731765 · Quality management system · MDR · notified body BSI Group The Netherlands B.V. · issued 2025-09-04 · expires 2027-10-30 · status: amended

## Source and citation

- Cite as: Lunit Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/lunit-inc (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/lunit-inc.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/lunit-inc
- 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.