Manufacturer
i-SENS
South KoreaLegal entities : i-SENS, Inc.
Markets : Croatia · Czechia · Estonia · Finland · Germany · Hungary · Italy · Netherlands · Northern Ireland · Poland · Portugal · Spain · Türkiye · United States
Approvals : EU – class IIb, A, C · United States (FDA) – 510(k) : 28 · class I, II · latest in 2026 · see on the FDA website
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a category to see competitors, a model to open its EUDAMED record.
| Category | EMDN code | Registered models | Class | Contact |
|---|---|---|---|---|
| Blood sugar monitoring systems - other | Z1204011599 |
|
IIb MDR | EUDAMED record Report an error |
| Blood gas analysers - with classic profile (pH, PO2, PCO2, hct + electrolytes) | W0201040101 | A IVDR | EUDAMED record Report an error | |
| Invasive blood sugar monitoring systems, single-use sensors | Z1204011585 | IIb MDR | EUDAMED record Report an error | |
| Ion selective electrolyte analysers | W0201040201 | A IVDR | EUDAMED record Report an error | |
| Blood glucose meters | W0201060102 | C IVDR | EUDAMED record Report an error | |
| Various diabetes monitoring instruments - other | W020106019099 | A IVDR | EUDAMED record Report an error | |
| Various rapid test chemistry / immunochemistry instruments - other | W0201069099 | A IVDR | EUDAMED record Report an error |
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