Manufacturer
Artronlab
CanadaLegal entities : Artron Laboratories Inc.
Markets : Hungary · Italy · Lithuania · Netherlands · Romania · United States
Approvals : EU – class C, D · United States (FDA) – 510(k) : 1 · class I, II · latest in 2006 · see on the FDA website
EU representative : MedNet EC-REP GmbH (Germany)
- 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 |
|---|---|---|---|---|
| Syphilis - RT & POC | W0105090105 | C IVDR, 98/79 | EUDAMED record Report an error | |
| Virology - RT & POC - other | W0105099099 | – 98/79 | EUDAMED record Report an error | |
| H. pylori - RT & POC | W0105090102 | – 98/79 | EUDAMED record Report an error | |
| Hbsag - RT & POC | W0105090201 | D IVDR, 98/79 | EUDAMED record Report an error | |
| HCV antibody -RT & POC | W0105090202 | D IVDR, 98/79 | EUDAMED record Report an error | |
| HIV 1 / 2 - RT & POC | W0105090302 | D IVDR, 98/79 | EUDAMED record Report an error | |
| Bacteriology - RT & POC - other | W0105090199 | – 98/79 | EUDAMED record Report an error | |
| Dengue - RT & POC | W0105099007 | – 98/79 | EUDAMED record Report an error |
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