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South Korea·KR-MF-000043626
Last updated September 17, 2026
Information
- Country
- South Korea
- Address
- 3-18, Eopseong 2-gil, Seobuk-gu, Cheonan-si, Chungcheongnam-do, South Korea
- Website
- genbody.co.kr
- —
- —
- [email protected]
- Phone
- +82 41 523 8990
- PRRC Contact
- Nam il Kim
- EUDAMED SRN
- KR-MF-000043626
- FDA FEI Number
- 3014660585
- DUNS Number
- 689451998
Catalogue (16)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ConfiGlu G1 Blood Glucose Meter Set | BGMGS001 | EUDAMED | Class C | Active |
| ConfiGlu G1 Glucose Control solution 3 | BGC003 | EUDAMED | Class C | Active |
| ConfiGlu G1 Blood Glucose Test Strip | BGSG001 | EUDAMED | Class C | Active |
| GenBody COVID-19 Ag | COVAG025-NU-1 | FDA UDI | N | Active |
| GenBody COVID-19 Ag | COVAG025-NU | FDA UDI | N | Active |
| GenBody COVID-19 Ag Home Test | COVAGHT2-U-5 | FDA UDI | N | Active |
| GenBody COVID-19 Ag | COVAG025-U | FDA UDI | N | Active |
| GenBody COVID-19 Ag Home Test | COVAGHT2-U-1 | FDA UDI | N | Active |
| GenBody COVID-19 Ag Home Test | COVAGHT2-U-25 | FDA UDI | N | Active |
| GenBody COVID-19 Ag Home Test | COVAGHT2-U-2 | FDA UDI | N | Active |
| Hemonitor H1 | HMGA101 | EUDAMED | Class B | Active |
| GenBody KET | DKET010 | EUDAMED | IVD General | Active |
| Hemonitor H1 microcuvette | HMAC050 | EUDAMED | Class A | Active |
| GenBody COVID-19 Ag Home Test | K251916 | FDA 510(k) | Class II | Active |
| HelicoSign Dry | HPYD050 | EUDAMED | IVD General | Active |
| Hemonitor H1 Control Set | HMCT001 | EUDAMED | Class B | Active |
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