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South Korea·KR-MF-000018333
Last updated June 8, 2026
Information
- Country
- South Korea
- Address
- 130-1, Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, Republic of Korea, Wonju, South Korea
- Website
- cu911.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Sung Ho Her
- EUDAMED SRN
- KR-MF-000018333
- FDA FEI Number
- —
- DUNS Number
- 689987964
Catalogue (62)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Oscillomitt, Models Cm 1050, Cm 1040, Cm 1030, Cm 1020, Cm 1010 | K000512 | FDA 510(k) | Class II | Active |
| Oscillomate Nibp / Sp02 Ems Monitor | K980879 | FDA 510(k) | Class II | Active |
| 740 Select | K140430 | FDA 510(k) | Class II | Active |
| Fore-Sight, Model Mc-2000 Series (mc-2000, Mc-2010, Mc2020, Mc2030) | K083892 | FDA 510(k) | Class II | Active |
| Adult Cerebral Oximeter, Model 2040 | K051257 | FDA 510(k) | Class II | Active |
| Oscillomate Neonatal Blood Press. Monit.-Model 901 | K860196 | FDA 510(k) | Class II | Active |
| Fore-Sight Absolute Cerebral And Somatic Oximeter, Mc 2000 Series, Models Mc2000, Mc2010, Mc2020, Mc2030 | K094030 | FDA 510(k) | Class II | Active |
| i-PAD | CSO-I-004-R1 | EUDAMED | Class IIb | Active |
| Defibrillation Electrode | CUA1007S | EUDAMED | Class IIb | Active |
| Pediatric Defibrillation Electrode | CUA0711P | EUDAMED | Class IIb | Active |
| i-PAD | CSO-I-004-R1 | EUDAMED | Class IIb | Active |
| Defibrillation Electrode | CUA1904S | EUDAMED | Class IIb | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (13)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 20, 2008 | Z-0462-2009 | — | terminated | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. |
| Sep 20, 2008 | Z-0465-2009 | — | terminated | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. |
| Sep 20, 2008 | Z-0467-2009 | — | terminated | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. |
| Sep 20, 2008 | Z-0466-2009 | — | terminated | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. |
| Sep 20, 2008 | Z-0469-2009 | — | terminated | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. |
| Sep 20, 2008 | Z-0463-2009 | — | terminated | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. |
| Sep 20, 2008 | Z-0461-2009 | — | terminated | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. |
| Sep 20, 2008 | Z-0464-2009 | — | terminated | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. |
| Sep 20, 2008 | Z-0470-2009 | — | terminated | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. |
| Sep 20, 2008 | Z-0471-2009 | — | terminated | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. |
| Sep 20, 2008 | Z-0468-2009 | — | terminated | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. |
| Jun 24, 2008 | Z-2203-2008 | — | terminated | Software: Audible alarm may be silenced if changed from the factory setting |
| May 24, 2004 | Z-1023-04 | — | terminated | Device may not alarm for %SpO2 value limit violations if a specific feature is enabled |