IVD instrumentsChemistry / immunochemistry instrumentsChemistry / immunochemistry rapid tests + POC tests
Various rapid test chemistry / immunochemistry instruments ("point of care" and/or emergency)
EMDN code W02010690
Manufacturers registered in Europe (EUDAMED) 6
- 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 |
|---|---|---|---|---|
| Apel EU representative : Medical Technology Promedt Consulting GmbH (Germany) | Japan |
|
A IVDR | Website sales@apel.co.jp EUDAMED record Report an error |
| Epocal FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) | Canada | A IVDR | Website contact@siemens-healthineers.com EUDAMED record Report an error | |
| Ginevri | Italy | A IVDR | Website mail@ginevri.com EUDAMED record Report an error | |
| PAL Finland | Finland |
|
– 98/79 | Website EUDAMED record Report an error |
| Seamaty EU representative : MedNet EC-REP GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) | United States | A IVDR | Website contact@siemens-healthineers.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) 11
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 |
|---|---|---|---|
| Circassia AB | United States | NIOX | K170983 (2017) |
| Caire Diagnostics Inc. Present in Europe in other categories | United States | CAIRE Diagnostics | K213611 (2023) |
| Bosch Healthcare Solutions GmbH Present in Europe in other categories | Germany | Vivatmo pro Oxycap Vivatmo pro Level 0 Spare part: Vivatmo pro handheld US Vivatmo pro Spare part: Vivatmo pro base station US | K243926 (2025) |
| Bedfont Scientific, Ltd. Present in Europe in other categories | United Kingdom | NObreath® FeNOBreath NOBreath | K203695 (2021) |
| Medical Graphics Corp. Present in Europe in other categories | United States | Fenom Flo™ | registered |
| Emsere, Inc | Netherlands | – | registered |
| LRE MEDICAL GMBH | Germany | – | registered |
| Medi Soft SA | Belgium | – | registered |
| Mgc Diagnostics Corporation | United States | – | K251674 (2025) |
| Sanner GmbH | Germany | – | registered |
| Spirosure, Inc. | United States | – | K182874 (2019) |
Didn't find it?
Tell us what you are looking for. Requests show us which categories to add first.