IVD instrumentsHematology / histology / cytology instrumentsHemostasis
Various hemostasis instruments
EMDN code W02020290
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 |
|---|---|---|---|---|
| Pro-med (Beijing) Technology EU representative : Sungo Cert GmbH (Germany) | China |
1 other |
A IVDR, 98/79 | EUDAMED record Report an error |
| Renderbio EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Beijing Lepu Medical Technology EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Medcaptain FDA EU representative : R Sight B.V. (Netherlands) | China | A IVDR | Website info@medcaptain.com EUDAMED record Report an error | |
| Tem Innovations FDA | Germany | A IVDR | EUDAMED record Report an error | |
| Haemonetics FDA EU representative : Haemonetics Italia s.r.l (Italy) | Switzerland | A IVDR | regulatoryeurope@haemonetics.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 |
|---|---|---|---|
| ACCRIVA DIAGNOSTICS HOLDINGS, INC. Present in Europe in other categories | United States | VerifyNow System VerifyNow Platelet Reactivity Test | registered |
| Helena Laboratories | United States | Helena Ristocetin Plateletworks Collagen Kit Plateletworks Combo-10 Kit Plateletworks Combo-25 Kit Plateletworks ADP Kit Plateletworks Combo-15 Kit | K023761 (2003) |
| Siemens Healthcare Diagnostics Products GmbH Present in Europe in other categories | Germany | Dade® PFA Trigger Solution PFA-100® System Dade® PFA Collagen/ADP Test Cartridge Dade® PFA Collagen/EPI Test Cartridge Dade® Cluster® Platelet Aggregation Reagents | registered |
| Aggredyne, Inc. | United States | Aggreguide AggreDYNE AA Assay | K181777 (2019) |
| BIT Analytical Solutions GmbH | Germany | – | registered |
| Fujimori Kogyo, Co., Ltd. | Japan | – | K191364 (2020) |
| Invetech Pty Ltd | Australia | – | registered |
| Leica Biosystems, division of Leica Microsystems, Inc. | United States | – | registered |
| Siemens Healthcare Diagnostics, Inc. Present in Europe in other categories | United States | – | registered |
| Sunphoria Co., Ltd. | Taiwan | – | registered |
| ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. Present in Europe in other categories | China | – | registered |
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