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Lunit Inc.

Active in EUDAMED

South Koreafrom SRN EUDAMED FDA SRN KR-MF-000005200 FEI 3021230777

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.

Devices
11
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 15 Nov 2026

Registries
  • EUDAMED 5
  • FDA GUDID 5
  • FDA 510(k) 4

A device listed in two registries counts in both.

Device classes
  • FDA Class II 6
  • EU Class IIa 5
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN KR-MF-000005200
  • FDA FEI 3021230777
  • DUNS 690102406

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 FEI
Authorised rep.
Obelis S.A.BE

Catalogue11

Newest first, rows 1-11 of 11

Search and filter all 11 devices
Skip device list

  • Lunit INSIGHT CXR Triage 1.0

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

  • Lunit INSIGHT CXR Triage 1.0

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

  • Lunit INSIGHT MMG (v1.1.10) Ref K260320

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

  • Lunit INSIGHT DBT (V1.2) Ref K253796

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

  • Lunit INSIGHT CXR Triage Ref K211733

    No data Registry: 510(k) Class:II

  • Lunit INSIGHT DBT v1.1 Ref K242652

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

  • Lunit INSIGHT MMG Ref 124012

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

  • Lunit INSIGHT CXR Ref 113212

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Lunit INSIGHT CXR Ref 113012

    Active Regimes: CE MDR 510(k) Registry: EUDAMED Class:IIa

  • Lunit INSIGHT DBT Ref 126012

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Lunit INSIGHT DBT Ref 126012

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

Rows 1-11 of 11

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
KR-MF-000005200
FDA FEI number
3021230777
DUNS number
690102406
EU VAT number
3148650626
EUDAMED status
Active
EUDAMED registered name
Lunit Inc.
Registered address
4-8 F, 374, Gangnam-daero, Gangnam-gu, 06241, Seoul, South Korea
PRRC contact
Sulgue Choi(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 30 Oct 2027

EUDAMED certificates (1)

BSI Group The Netherlands B.V. 2797 1 certificate

  • MDR 731765 Expiring Amended Expires in 349 days

    Quality management system EU MDR

    Issued
    4 Sep 2025
    Expires
    30 Oct 2027
    Reason
    Other

Frequently asked questions

How many devices does Lunit Inc. have in the registry?

The registry currently lists 11 devices for Lunit Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Lunit Inc.'s devices?

Among its 11 most recently registered devices, Lunit Inc. has devices listed in EUDAMED (5 devices), FDA 510(k) (4 devices) and FDA GUDID (5 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Lunit Inc.'s devices fall under?

Among its 11 most recently registered devices, the classes recorded for Lunit Inc.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Lunit Inc.?

EUDAMED lists 1 certificate for Lunit Inc. (quality management system) under MDR. The most recent was issued on 4 Sep 2025.

What are the newest devices from Lunit Inc. in the registry?

The most recently registered devices listed for Lunit Inc. include Lunit INSIGHT CXR Triage 1.0, Lunit INSIGHT MMG (v1.1.10), Lunit INSIGHT DBT (V1.2) and Lunit INSIGHT CXR Triage.

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