Manufacturer
B&E Bio-Technology
ChinaLegal entities : B&E BIO-TECHNOLOGY CO., LTD.
Markets : Austria · Netherlands · Spain · United States
Approvals : EU – class A · United States (FDA) – · class I, II
EU representative : SUNGO Europe B.V. (Netherlands)
- 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 |
|---|---|---|---|---|
| Blood gas analysers - consumables | W0201040185 | – 98/79 | EUDAMED record Report an error | |
| Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids) | W0103010105 | A IVDR | EUDAMED record Report an error | |
| Glycosilated hemoglobin devices | W0201060101 | A IVDR, 98/79 | EUDAMED record Report an error | |
| Automated whole blood hematology analysers - IVD medical device software | W0202010192 |
|
– 98/79 | EUDAMED record Report an error |
| Haemoglobin controls | W0103010504 | – 98/79 | EUDAMED record Report an error | |
| Ion selective electrolyte analysers | W0201040201 | A IVDR | EUDAMED record Report an error | |
| Other haemoglobin (types) testing - other | W0103010299 | A IVDR | EUDAMED record Report an error | |
| Various hematology / histology / cytology instruments - other | W02029099 |
|
A IVDR | EUDAMED record Report an error |
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