Haematology / haemostasis / immunohaematology / histology / cytologyHaemostasis reagents (coagulation)General coagulation tests
Thrombin time / reptilase / batroxobin time
EMDN code W0103020103
Manufacturers registered in Europe (EUDAMED) 27
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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Other manufacturers known in the United States (FDA) 2
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 |
|---|---|---|---|
| Helena Laboratories | United States | Thrombin Clotting Time Reagent | K920147 (1992) |
| Siemens Healthcare Diagnostics, Inc. Present in Europe in other categories | United States | – | registered |
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