Microbiology instruments (cultures)Microbiology susceptibility / identificationAntibiotic susceptibility analysers
Antibiotic susceptibility analysers - hardware accessories
EMDN code W0203010180
Manufacturers registered in Europe (EUDAMED) 10
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| bioMérieux FDA EU representative : bioMérieux SA (France) | United States | A IVDR | EUDAMED record Report an error | |
| Beckman Coulter FDA EU representative : Beckman Coulter Ireland Inc. (Ireland) | United States | A IVDR | Website EUDAMED record Report an error | |
| Intelligence Artificielle Applications | France | A IVDR | Website EUDAMED record Report an error | |
| Becton Dickinson FDA EU representative : Becton Dickinson Ireland Limited (Ireland) | United States | A IVDR | Website EUDAMED record Report an error | |
| Copan Wasp FDA | Italy |
|
A IVDR | Website regulatory.wasp@copangroup.com EUDAMED record Report an error |
| Erba | Czechia | A IVDR | Website EUDAMED record Report an error | |
| Gradientech | Sweden | A IVDR | Website info@gradientech.se EUDAMED record Report an error | |
| Mast Group FDA EU representative : Mast Diagnostica GmbH (Germany) | United Kingdom (ex Northern Ireland) | A IVDR | Website sales@mastgrp.com EUDAMED record Report an error | |
| Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Q-linea FDA | Sweden | A IVDR | Website regulatory@qlinea.com EUDAMED record Report an error |
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 3
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Trek Diagnostic Systems, Inc. Present in Europe in other categories | United States | Sensititre Sensititre AIM™ Sensititre™ OptiRead™ Thermo Scientific™ Sensititre™ ARIS HiQ™ System STP8F | K110583 (2011) |
| Remel Co. Present in Europe in other categories | United States | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES THE SENSITITRE AIM Sensititire® OptiRead™ | registered |
| Thermo Fisher Scientific Present in Europe in other categories | United States | – | K191914 (2019) |
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