Manufacturer
PaxGenBio
South KoreaLegal entities : PaxGenBio Co., Ltd.
Markets : Czechia · Germany
Approvals : EU – class A
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
- 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 |
|---|---|---|---|---|
| Full genotyping high-risk + low-risk HPV - NA reagents | W0105041004 | – 98/79 | EUDAMED record Report an error | |
| Mycobacterial detection by NA reagents | W0105010703 | – 98/79 | EUDAMED record Report an error | |
| Coronavirus - NA reagents | W0105041106 | – 98/79 | EUDAMED record Report an error | |
| Partial genotyping high-risk HPV - NA reagents | W0105041003 | – 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 |
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