Manufacturer
Sugentech
South KoreaLegal entities : Sugentech, Inc.
Markets : Spain · United States
Approvals : EU – class A, B · United States (FDA) – 510(k) : 1 · class I, II · latest in 2016 · 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 |
|---|---|---|---|---|
| Limited panel immunochemistry analysers - other | W0201020299 | A IVDR | EUDAMED record Report an error | |
| Automated immunochemistry analysers - low routine (throughput <= 100 test/h) | W0201020101 | A IVDR | EUDAMED record Report an error | |
| Blood collection, capillary tubes | W0501010203 | A IVDR | EUDAMED record Report an error | |
| Limited panel immunochemistry analysers - IVD medical device software | W0201020292 | B IVDR | EUDAMED record Report an error | |
| Urine strip readers | W020101020101 | B IVDR | EUDAMED record Report an error | |
| Various rapid test chemistry / immunochemistry instruments - other | W0201069099 | A IVDR | EUDAMED record Report an error |
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
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