Manufacturer
Apexbio
TaiwanLegal entities : Apex Biotechnology Corp.
Markets : Germany · United States
Approvals : EU – class A · United States (FDA) – 510(k) : 35 · class I, II · latest in 2025 · see on the FDA website
EU representative : Obelis s.a. (Belgium)
- 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 |
|---|---|---|---|---|
| Glycosilated hemoglobin devices | W0201060101 | A 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 - hardware accessories | W0201069080 |
|
A IVDR, 98/79 | EUDAMED record Report an error |
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