Manufacturer
Hunan Ehome Health Technology
ChinaLegal entities : Hunan Ehome Health Technology Co., Ltd.
Markets : France · Italy · Romania · Spain
Approvals : EU – class A
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
- 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 |
|---|---|---|---|---|
| Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids) | W0103010105 | A IVDR | EUDAMED record Report an error | |
| Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr) | W0202010101 | A IVDR, 98/79 | EUDAMED record Report an error | |
| D-dimer | W0103020503 | – 98/79 | EUDAMED record Report an error | |
| Normal blood controls | W0103010501 | A IVDR, 98/79 | EUDAMED record Report an error | |
| Semi-automated hematology analysers | W0202010202 | A IVDR | EUDAMED record Report an error | |
| Whole blood calibrators | W0103010507 | – 98/79 | EUDAMED record Report an error | |
| Blood collection, capillary tubes | W0501010203 | A IVDR | EUDAMED record Report an error | |
| Haematology controls - other | W0103010599 | – 98/79 | EUDAMED record Report an error | |
| Interleukin 6 (il-6) | W01030609 |
|
– 98/79 | EUDAMED record Report an error |
| IVD general use consumables devices - other accessories | W0580 | A IVDR | EUDAMED record Report an error |
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