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Sign in to claim this brandLunit Inc.
South Korea·KR-MF-000005200
Last updated September 17, 2026
Information
- Country
- South Korea
- Address
- 4-8 F, 374, Gangnam-daero, Gangnam-gu, Seoul, South Korea
- Website
- lunit.io
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Sulgue Choi
- EUDAMED SRN
- KR-MF-000005200
- FDA FEI Number
- 3021230777
- DUNS Number
- 690102406
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Lunit INSIGHT CXR Triage | 1.0 | FDA UDI | Class II | Active |
| Lunit INSIGHT CXR Triage | 1.0 | FDA UDI | Class II | Active |
| Lunit INSIGHT MMG (v1.1.10) | K260320 | FDA 510(k) | Class II | Active |
| Lunit INSIGHT DBT (V1.2) | K253796 | FDA 510(k) | Class II | Active |
| Lunit INSIGHT DBT v1.1 | K242652 | FDA 510(k) | Class II | Active |
| Lunit INSIGHT MMG | 124012 | EUDAMEDFDA UDI | Class IIa | Active |
| Lunit INSIGHT CXR | 113012 | EUDAMEDFDA 510(k) | Class IIa | Active |
| Lunit INSIGHT DBT | 126012 | EUDAMEDFDA UDI | Class IIa | Active |
| Lunit INSIGHT DBT | 126012 | EUDAMEDFDA UDI | Class IIa | Active |
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Authorised Representatives
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