Manufacturer
Dynex Technologies
United StatesLegal entities : Dynex Technologies Inc
Markets : Germany · Netherlands · Spain · United States
Approvals : EU – class A · United States (FDA) – 510(k) : 1 · class I, II · latest in 2023 · see on the FDA website
EU representative : Acorn Regulatory Consultancy Services Ltd (Ireland)
- 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 |
|---|---|---|---|---|
| Automated immunochemistry analysers - low routine (throughput <= 100 test/h) | W0201020101 |
|
A IVDR | EUDAMED record Report an error |
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