Manufacturer
Orphée
SwitzerlandLegal entities : Orphée SA
First countries of placing on the market declared in EUDAMED : Poland
EU representative : PZ CORMAY Spółka Akcyjna (Poland)
- 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 |
4 others |
A IVDR | EUDAMED record Report an error |
| Multilevel blood controls | W0103010503 | – 98/79 | EUDAMED record Report an error | |
| Normal blood controls | W0103010501 |
|
– 98/79 | EUDAMED record Report an error |
| Automated 3 part hematology analysers | W0202010201 | – 98/79 | EUDAMED record Report an error | |
| Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr) | W0202010101 | – 98/79 | EUDAMED record Report an error | |
| Whole blood calibrators | W0103010507 |
|
– 98/79 | EUDAMED record Report an error |
| Automated whole blood hematology analysers - consumables | W0202010185 | A IVDR | EUDAMED record Report an error |
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