Manufacturer
HemoCue
SwedenLegal entities : HemoCue AB
Markets : Austria · Bulgaria · Croatia · Cyprus · Czechia · Denmark · Estonia · Finland · France · Germany · Greece · Hungary · Iceland · Ireland · Italy · Lithuania · Malta · Netherlands · Norway · Poland and 7 more countries
Approvals : EU – class A · United States (FDA) – 510(k) : 15 · class I, II · latest in 2020 · see on the FDA website
- 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 |
|---|---|---|---|---|
| Rapid test hematology / histology / cytology instruments - other | W02020699 | A IVDR | EUDAMED record Report an error | |
| White blood cells (wbc) | W0103010604 |
|
– 98/79 | EUDAMED record Report an error |
| Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr) | W0202010101 | A IVDR | EUDAMED record Report an error | |
| Haemoglobin (hb) | W0103010601 |
|
– 98/79 | EUDAMED record Report an error |
| Limited panel cell counting analysers - other | W0202010299 |
|
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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