ReagentsHaematology / haemostasis / immunohaematology / histology / cytologyHaemostasis reagents (coagulation)
Platelet factors
EMDN code W01030204
Manufacturers registered in Europe (EUDAMED) 13
- 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 |
|---|---|---|---|---|
| Hartbio FDA EU representative : Amstermed UK Ltd (Northern Ireland) | United Kingdom (ex Northern Ireland) | – 98/79 | EUDAMED record Report an error | |
| Stago FDA | France |
2 others
|
– 98/79 | EUDAMED record Report an error |
| HYPHEN BioMed FDA | France | C IVDR | Website info@hyphen-biomed.com EUDAMED record Report an error | |
| Pro-med (Beijing) Technology EU representative : Sungo Cert GmbH (Germany) | China |
|
– 98/79 | EUDAMED record Report an error |
| Immucor FDA EU representative : IMMUCOR Medizinische Diagnostik GmbH (Germany) | United States | A, C IVDR | EUDAMED record Report an error | |
| Milenia Biotec | Germany | – 98/79 | Website info@milenia-biotec.de EUDAMED record Report an error | |
| Beijing Lepu Medical Technology EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands) | China | – 98/79 | EUDAMED record Report an error | |
| Instrumentation Laboratory FDA EU representative : Instrumentation Laboratory SpA (Italy) | United States | B IVDR | Website Regulatory@werfen.com EUDAMED record Report an error | |
| Siemens Healthcare Diagnostics Products FDA | Germany | B IVDR | Website contact@siemens-healthineers.com EUDAMED record Report an error | |
| Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain) | China |
|
– 98/79 | EUDAMED record Report an error |
| Medcaptain FDA EU representative : R Sight B.V. (Netherlands) | China | C IVDR, 98/79 | Website info@medcaptain.com EUDAMED record Report an error | |
| Tcoag FDA | Ireland | B IVDR | Website EUDAMED record Report an error | |
| Tellgencorp EU representative : Medunion S.L. (Spain) | China |
|
– 98/79 | Website sales@tellgen.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) 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 |
|---|---|---|---|
| AKERS BIOSCIENCES, INC. | United States | PIFA PLUSS® PF4 Rapid Assay PIFA® Heparin/PF4 Rapid Assay | registered |
| Biokit, S.A. Present in Europe in other categories | Spain | – | registered |
Didn't find it?
Tell us what you are looking for. Requests show us which categories to add first.
Related categories
- Fibrinolysis132 manufacturers
- Haemostasis rapid tests - RT & POC56 manufacturers
- Coagulation factors53 manufacturers
- General coagulation tests52 manufacturers
- Haemostasis calibrators/controls45 manufacturers
- Coagulation inhibitors/thrombophilia markers44 manufacturers
- Special coagulation tests31 manufacturers
- Auxiliary reagents and supplements (haemostasis)20 manufacturers
- Haemostasis reagents - other9 manufacturers
- Parent category : Haemostasis reagents (coagulation)207 manufacturers