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South Korea·KR-MF-000009173
Last updated September 17, 2026
Information
- Country
- South Korea
- Address
- 43, Banpo-daero 28-gil, Seocho-gu, Seoul, South Korea
- Website
- i-sens.com/
- —
- —
- [email protected]
- Phone
- 855-646-3231
- PRRC Contact
- Jeong Hwa Lee
- EUDAMED SRN
- KR-MF-000009173
- FDA FEI Number
- 3005621222
- DUNS Number
- 688840958
Catalogue (108)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Caresens N Link Blood Glucose Monitoring System; Caresens N Link Multi Blood Blucose Monitoring System | K130696 | FDA 510(k) | Class II | Active |
| i-Smart 30 Electrolyte Analyzer | POCEAL001 | EUDAMED | Class A | Active |
| alphacheck professional Lancing Device | - | EUDAMED | Class I | Active |
| emVia Lancing Device | - | EUDAMED | Class I | Active |
| i-Smart 300 Blood Gas Analyzer | POCBGAL001 | EUDAMED | Class A | Active |
| CareSens Air Continuous Glucose Monitoring System | CGM-ST-002 | EUDAMED | Class IIb | Active |
| i-SmartCare 10 Blood Gas Analyzer | POCBGAL002 | EUDAMED | Class A | Active |
| i-Smart 30 PRO Electrolyte Analyzer | POCEAL002 | EUDAMED | Class A | Active |
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