Is this your brand? Sign in to claim ownership.
Sign in to claim this brandCU Medical Systems, Inc.
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 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Fore-Sight® | 01-07-1007 | FDA UDI | Class II | Active |
| Fore-Sight Elite | 01-06-1100 | FDA UDI | Class II | Active |
| Fore-Sight® | 01-07-1006 | FDA UDI | Class II | Active |
| Fore-Sight® | 01-07-1004 | FDA UDI | Class II | Active |
| Fore-Sight Elite® | 01-07-1101 | FDA UDI | Class II | Active |
| Fore-Sight® | 01-07-1005 | FDA UDI | Class II | Active |
| Fore-Sight Elite | 01-07-4103 | FDA UDI | Class II | Active |
| Fore-Sight Elite® | 01-06-3014 | FDA UDI | Class II | Active |
| Fore-Sight® | 01-06-0005 | FDA UDI | Class II | Active |
| Fore-Sight® | 01-07-1002 | FDA UDI | Class II | Active |
| Fore-Sight Elite® | 01-06-3000 | FDA UDI | Class II | Active |
| Fore-Sight Elite® | 01-07-1103 | FDA UDI | Class II | Active |
| Fore-Sight Elite® | 01-07-1100 | FDA UDI | Class II | Active |
| Fore-Sight® | 01-07-1000 | FDA UDI | Class II | Active |
| Fore-Sight® | 01-06-0043 | FDA UDI | Class II | Active |
| Fore-Sight Elite | 01-06-1001 | FDA UDI | Class II | Active |
| Fore-Sight Elite® | 01-06-3100 | FDA UDI | Class II | Active |
| Fore-Sight® | 01-07-1003 | FDA UDI | Class II | Active |
| Fore-Sight Elite® | 01-06-3101 | FDA UDI | Class II | Active |
| Fore-Sight Elite® | 01-07-1102 | FDA UDI | Class II | Active |
| i-PAD | NF1200 | FDA UDI | Class III | Active |
| Fore-Sight Elite | 01-06-1000 | FDA UDI | Class II | Active |
| i-PAD | CSO-I-004-R1 | EUDAMED | Class IIb | Active |
| i-PAD | CSO-I-004-R1 | EUDAMED | Class IIb | Active |
| LiFEGAIN | CSO-I-004-R1 | EUDAMED | Class IIb | Active |
| Oscillomate Non-Invasive Blood Pressure Monitor | K972020 | FDA 510(k) | Class II | Active |
| Neoguard Ecg Electrodes | K861364 | FDA 510(k) | Class II | Active |
| Neoguard Chest Percussor | K853965 | FDA 510(k) | Class II | Active |
| 740 Select | K150620 | FDA 510(k) | Class II | Active |
| 740 Select | K130411 | FDA 510(k) | Class II | Active |
| Oscillomate Blood Pressure Monitor-Model 9300 | K925402 | FDA 510(k) | Class II | Active |
| Oscillomate Ems Nibp Monitor Model 9001 | K982135 | FDA 510(k) | Class II | Active |
| FORE-SIGHT Elite Absolute Tissue Oximeter | K143675 | FDA 510(k) | Class II | Active |
| Neoguard Reflector | K853794 | FDA 510(k) | Class II | Active |
| Model 750e Series Monitor | K051896 | FDA 510(k) | Class II | Active |
| FORE-SIGHT ELITE Module Tissue Oximeter | K180003 | FDA 510(k) | Class II | Active |
| Fore-Sight Cerebral Oximeter Monitor, Model 2040 | K061960 | FDA 510(k) | Class II | Active |
| Fore-Sight, Mc-2000 Series | K073036 | FDA 510(k) | Class II | Active |
| Fore-Sight, Model Mc-2000 Series (mc 2000, Mc2010, Mc-2020, Mc2030) | K091452 | FDA 510(k) | Class II | Active |
| Fore-Sight Elite Absolute Tissue Oximeter | K133879 | FDA 510(k) | Class II | Active |
| Fore-Sight Elite Absolute Tissue Oximeter | K123700 | FDA 510(k) | Class II | Active |
| Fore-Sight Absolute Tissue Oximeter | K112820 | FDA 510(k) | Class II | Active |
| 9303 Neonatal/Adult Vital Signs Monitor | K982776 | FDA 510(k) | Class II | Active |
| Oscillomate Blood Pressure Monitor-Model 915 | K860488 | FDA 510(k) | Class II | Active |
| Oscillomate (tm) Blood Pressure Monitor-Model 1630 | K911722 | FDA 510(k) | Class II | Active |
| Modification To Model 750 Series Monitor | K063087 | FDA 510(k) | Class II | Active |
| 750c Series Monitor, Models 750c-2ms, 750cm-2ms, 750c-Nnl, 750cm-2nl, 750c-3ms, 750cm-3ms, 750c-3nl, 750cm-3nl | K050844 | FDA 510(k) | Class II | Active |
| Klear-Temp | K926030 | FDA 510(k) | Class II | Active |
| Cas 740 Series Monitor, Models 740-1, 740m-1, 740-2ms, 740m-2ms, 740-2nl, 740m-2nl, 740-2nn, 740m-2nn, 740-3ms, 740m-3ms | K033048 | FDA 510(k) | Class II | Active |
| FORE-SIGHT ELITE Tissue Oximeter Module | K190270 | FDA 510(k) | Class II | 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 |