ReagentsHaematology / haemostasis / immunohaematology / histology / cytology
Monoclonal antibodies / flow cytometry
EMDN code W010308
Manufacturers registered in Europe (EUDAMED) 26
- 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.
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Other manufacturers known in the United States (FDA) 5
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 |
|---|---|---|---|
| Becton, Dickinson & CO Present in Europe in other categories | United States | FACSCanto BD FACSuite FACS BD FACSLyric BD Multitest | K201814 (2020) |
| Boule Diagnostics AB Present in Europe in other categories | Sweden | – | registered |
| Flextronics International USA, Inc. | United States | – | registered |
| STRATEC SE Present in Europe in other categories | Germany | – | registered |
| STRATEC Switzerland AG c/o STRATEC SE | Germany | – | registered |
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