Manufacturer
MedicalSystem Biotechnology
ChinaLegal entities : MedicalSystem Biotechnology Co., Ltd.
Markets : France · Italy · United States
Approvals : EU – class A · United States (FDA) – · class I
EU representative : Lotus NL B.V. (Netherlands)
- 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 |
|---|---|---|---|---|
| Complete cell count | W0103010103 | A IVDR | EUDAMED record Report an error | |
| D-dimer | W0103020503 | – 98/79 | EUDAMED record Report an error | |
| Cellular enzyme determination reagents (g-6-pdh, pyruvate kinase) | W0103019001 | – 98/79 | EUDAMED record Report an error | |
| Fibrinogen assays (factor i) | W0103020201 | – 98/79 | EUDAMED record Report an error | |
| Fibrinogen degradation products | W0103020502 | – 98/79 | EUDAMED record Report an error | |
| Influenza & para influenza - NA reagents | W0105040504 | – 98/79 | EUDAMED record Report an error | |
| Interleukin 6 (il-6) | W01030609 | – 98/79 | EUDAMED record Report an error | |
| Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus | W0105900101 | A IVDR | EUDAMED record Report an error | |
| Syphilis antibody assays total | W0105010302 | – 98/79 | EUDAMED record Report an error | |
| Virology - NA reagents - other | W0105040599 | – 98/79 | EUDAMED record Report an error |
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