Manufacturer
Shanghai Kehua Laboratory System
ChinaLegal entities : Shanghai Kehua Laboratory System Co., Ltd.
Markets : Italy · United States
Approvals : EU – class A · United States (FDA) – · class I
EU representative : Obelis s.a. (Belgium)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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| Category | EMDN code | Registered models | Class | Contact |
|---|---|---|---|---|
| Automated immunochemistry analysers - moderate to high routine (throughput > 250 and <= 700 test/h) | W0201020103 | A IVDR | EUDAMED record Report an error | |
| Chemistry analysers - low routine (random access without ise mode test/h <= 400) | W0201010101 | A IVDR | EUDAMED record Report an error | |
| Immunochemistry instruments - other | W02010299 | A IVDR | EUDAMED record Report an error | |
| Immunochemistry readers | W0201020201 | A IVDR | EUDAMED record Report an error |
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