IVD instrumentsHematology / histology / cytology instrumentsHemostasis
Coagulometers
EMDN code W02020201
Manufacturers registered in Europe (EUDAMED) 54
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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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) 25
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 |
|---|---|---|---|
| Haemonetics Corp. Present in Europe in other categories | United States | TEG5000 TEG5000 HEMOSTASIS SYSTEM TEG5000 HEMOSTASIS ANALYZER TEG HEMOSTASIS SYSTEM TEG6s HEMOSTASIS SYSTEM Global Hemostasis - HN | K251024 (2025) |
| Tem Innovations GmbH Present in Europe in other categories | Germany | ROTEM® | K201440 (2022) |
| Medtronic, Inc. Present in Europe in other categories | United States | CLOTtrac™ RACT CLOTtrac® HEPtrac® HEPline® | registered |
| Helena Laboratories | United States | Cascade M-4 (110V/220V) AggRAM Analyzer, Windows 7 (110V/220V) AggRAM Analyzer, Windows 2000 (110V/220V) AggRAM Module (110/220 V) AggRAM Analyzer (110V/220V) Actalyke QC Kit - AQC-LP | K061014 (2006) |
| R & D Batteries, Inc. | United States | R&D Batteries, Inc. | K934747 (1993) |
| SIENCO, INC. | United States | Sonoclot® SonACT Kit Sonoclot® kACT Kit Sonoclot® NonActivated Kit Sonoclot® Reference Viscosity Oil Quality Control Kit Sonoclot® Reference Plasma Quality Control Kit | K260909 (2026) |
| Analytical Control Systems, Inc. | United States | Whole Blood Control Level I .02M Calcium Chloride Hemotec Whole Blood Control Kit Large Whole Blood Control Level III Whole Blood Control Level II | K925340 (1993) |
| TCOAG IRELAND LIMITED Present in Europe in other categories | Ireland | KC® 1 Delta Destiny Plus KC® 4 Delta TriniCAL™ Reference Plasma Destiny MAX Analyzer | registered |
| Bio/Data Corp. Present in Europe in other categories | United States | PAP-8E Software CD Tris Buffered Saline Lupus Anticoagulant Confirmation Reagent Sodium Citrate | K893650 (1989) |
| Biokit, S.A. Present in Europe in other categories | Spain | BIO-FLASH | registered |
| BEMOTEC GmbH | Germany | – | registered |
| BIT Analytical Solutions GmbH | Germany | – | registered |
| Bernd Richter GmbH | Germany | – | registered |
| Bionostics, Inc. | United States | – | registered |
| DIAGNOSTIC GRIFOLS SA Present in Europe in other categories | Spain | – | K183390 (2019) |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | – | registered |
| Invetech Pty Ltd | Australia | – | registered |
| KMC Systems | United States | – | registered |
| Leica Biosystems, division of Leica Microsystems, Inc. | United States | – | registered |
| Pentapharm AG Present in Europe in other categories | United States | – | K083842 (2010) |
| SEKISUI MEDICAL CO., LTD. | Japan | – | K173202 (2018) |
| SUNRISE TECHNOLOGIES, S.A.U. | Spain | – | registered |
| Siemens Healthcare Diagnostic Products GmbH Present in Europe in other categories | Germany | – | K172286 (2017) |
| Siemens Healthcare Diagnostics, Inc. Present in Europe in other categories | United States | – | K083159 (2009) |
| Thermo Fisher Scientific Present in Europe in other categories | United States | – | registered |
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