Haematology and haemotransfusion devices
EMDN code B
Manufacturers registered in Europe (EUDAMED) 96
- 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.
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) 126
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 |
|---|---|---|---|
| Andreas Hettich GmbH Present in Europe in other categories | Germany | Bucket Swing-out rotor Angle rotor ROTANTA 460 RF ROTANTA 460 RC ROTANTA 460 | registered |
| Fresenius Kabi AG Present in Europe in other categories | Germany | ATF 120 Fast Start Kit ATY Y-Adapter ATO Oxygenator line ATV-F140C Vacuum Lines Combi-pack AT1 Autotransfusion Set ATV-180 Vacuum Line | K210089 (2021) |
| TELEFLEX INCORPORATED Present in Europe in other categories | United States | PLEUR-EVAC PLEUR EVAC | registered |
| LIVANOVA USA, INC. Present in Europe in other categories | Germany | BRAT Accessory Orthofuser Drain Line Crit-Line Cuvette XVAC XTRA | registered |
| AEON BIOTHERAPEUTICS CORP. | Taiwan | Aeon CPKit Virtue CPKit Aeon ACKit Virtue ACKit Transcend PRP | registered |
| Thermo Electron LED GmbH | – | Thermo Scientific Thermo Scientific Sorvall Lynx | registered |
| Terumo Cardiovascular Systems Corporation | United States | Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. Capiox® SX Hollow Fiber Oxygenator with Hardshell Reservoir Capiox® Flexible Venous Reservoir NX19 Oxygenator w/4-liter reservoir; left-side outlet port NX19 Oxygenator w/4-liter reservoir; right-side outlet port | K153143 (2015) |
| Changsha Yingtai Instrument Co., Ltd Present in Europe in other categories | China | Yingtai | registered |
| 3t Medical Systems, LLC | United States | CBCII ConstaVac ConstaVac CBC II Constavac CBC III Constavac CBCII Ambulating Bulb | registered |
| INTRA-LOCK INTERNATIONAL, INC. | – | IntraSpin Intra-Lock | registered |
| BIOTECHNOLOGY INSTITUTE SL | – | ENDORET KIT ENDORET KIT | registered |
| Bimini Technologies LLC | – | MedGeneRx PRP ProGen PRP Eclipse ProGen PRP Advantage Gold Rush PRP Healeon HD PRP GENESIS PRP 15mL Concentrating System | registered |
| APEX BIOLOGIX , LLC | United States | XCELL | registered |
| Celling Biosciences | – | Celling ART PRP System Celling ART PRP 2-Step Celling ART PRP 2-Step 120 Kit Celling ART PRP 2-Step 60 Kit Celling ART PRP 2-Step Mini Kit | registered |
| BIOHORIZONS IMPLANT SYSTEMS, INC Present in Europe in other categories | United States | BioHorizons | registered |
| ROYAL BIOLOGICS INC. | United States | FIBRINET SeriVium AlVeo MAXX PRP MAXX BMC MAXX | registered |
| Nuo Therapeutics, Inc. | United States | Angel Whole Blood Processing System Angel Processing Sets (NA) Angel Processing Sets (EU) Angel Whole Blood Processing System Machine - EU - Reworked Angel Blood Access Kits (NA) Angel Blood Access Kits | registered |
| Avanos Medical, Inc. | United States | PROLONG* Continuous Nerve Block Set PROLONG* Continuous Nerve Block Set with NRFit™ Connector | registered |
| CENTRON CORPORATION | South Korea | Rapid Seal Tube Sealer SE530 Rapid Seal Tube Sealer SE330 Rapid Seal Tube Sealer SE470 Rapid Seal Tube Sealer SE340 Rapid Seal Tube Sealer SE540 MacoSeal SE160 | registered |
| ECLIPSE | United States | Eclipse PRP Eclipse PRP HC Qigenix PRP | registered |
| Bellus Medical, LLC | United States | Progen PRP Eclipse | registered |
| DSM BIOMEDICAL, INC. | United States | PEAK® Platelet Rich Plasma System GENIUS Blood and Marrow Concentration (BM/C) System DSM Biomedical Centrifuge | registered |
| SUNEVA MEDICAL, INC. | – | Amplifine | registered |
| Bahia Medical Inc. | United States | MARGENIX Goldrush Genesis | registered |
| Davol, Inc. | United States | SURETRANS | K931899 (1994) |
| EXOCUBE BIYOTEKNOLOJI ANONIM SIRKETI | Türkiye | ExoCube-20Pack ExoCube Centrifuge Container Set Exocube Set | registered |
| Factor Medical, Inc. Present in Europe in other categories | United States | SELPHYL® Selphyl PRFM Tube Selphyl PRP Tube | registered |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein | registered |
| ALLIANCE PARTNERS LLC | – | Cyclone Concentrating System Cyclone Platelet Rich Plasma (PRP) Concentrating System | registered |
| EMCYTE CORP. | United States | PurePRP Supraphysiologic 30mL GenesisCS Component Concentrating System PurePRP Supraphysiologic 60mL GenesisCS Component Concentrating System PurePRP Supraphysiologic 120mL GenesisCS Component Concentrating System | registered |
| FENWAL, INC. | – | ALYX™ 2RBC-LR Kit ALYX™ RBC/Plasma Kit ALYX 2RBC LR Kit with Saline Spike | registered |
| Sarstedt Aktiengesellschaft & Co.KG | – | Multisealer MS 500M Multi Sealer MS 1000 Multisealer MS 500B | registered |
| VERTICAL SPINE, LLC | – | FIBRINET® FIBRINET | registered |
| CELLMEDIX HOLDINGS, LLC | – | Centripid PC ProGen PC Kit | registered |
| Circulatory Technology, Inc. | United States | Bigger Better-Bladder Better-Bladder | K140321 (2014) |
| Rmedica Co.,Ltd Present in Europe in other categories | South Korea | Dr.PRP | registered |
| ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. | United States | H.A.S.® | registered |
| Allied Medical, LLC Present in Europe in other categories | United States | PC | registered |
| GALE FORCE AESTHETICS, LLC | United States | Illuminate PRP | registered |
| GLOBAL BLOOD RESOURCES LLC | United States | Global Blood Resources | K031150 (2003) |
| ITL ASIA PACIFIC SDN. BHD. Present in Europe in other categories | – | CrocClamp™ (Non-Reopening Clamp) | registered |
| Inquis Medical, Inc. | United States | Aventus Thrombectomy System - Clot Management System | K240426 (2024) |
| Luvo Medical Technologies, Inc. Present in Europe in other categories | Canada | World PRP | registered |
| ORTHOASCENT, LLC | United States | ASCENT FLEXXPRP | registered |
| Procell Surgical (us) Inc. | Canada | ProCell Surgical Sponge-Blood Recovery Unit | K193361 (2020) |
| Spectrum Medical , Ltd. Present in Europe in other categories | United Kingdom | Quantum Perfusion Hybrid System | K241206 (2024) |
| 3BY Ltd. | Israel | – | registered |
| AB Elektronik-Konstruktion Innovation (Abelko) | Sweden | – | registered |
| AIKEN CORP. | United States | – | registered |
| Advanced Molding Technologies | United States | – | registered |
| Amphenol Critical Medical Technologies, LLC | United States | – | registered |
| Atrium Medical Corp. | United States | – | K201305 (2021) |
| B.T.I. BIOTECHNOLOGY | Spain | – | registered |
| Biobase Biodustry(Shandong)Co., Ltd. | China | – | registered |
| Biocells Discoveries Internacional (Biocells) | Ecuador | – | registered |
| Biogenomics S.A.C. - Biocells Surgical | Peru | – | registered |
| Bioprod d.o.o. | Slovenia | – | registered |
| Comar LLC | United States | – | registered |
| Comar LLC / PCI | United States | – | registered |
| Conroy Medical AB | Sweden | – | registered |
| Crosmed S.A. | Argentina | – | registered |
| DSV Contract Logistics | Mexico | – | registered |
| Dermaqual | United States | – | registered |
| Evoskin LLC | United States | – | registered |
| Farmaco Quimica Nacional, S.A. | Dominican Republic | – | registered |
| Flextronics International USA, Inc. | United States | – | registered |
| GVS TM, Inc. | United States | – | registered |
| Geckeler | United States | – | registered |
| Genesis Biologics, Inc. | United States | – | registered |
| Globus Medical, Inc. Present in Europe in other categories | United States | – | registered |
| Greens Surgicals Private Limited | India | – | registered |
| Guangxi Ehall Medical Technology Co.,Ltd | China | – | registered |
| HARMAC MEDICAL PRODUCTS, INC. | United States | – | registered |
| HUNAN XIANG YI LABORATORY INSTRUMENT DEVELOPMENT CO., LTD Present in Europe in other categories | China | – | registered |
| High Technology, Inc. Present in Europe in other categories | United States | – | registered |
| Hospital & Homecare Imp. & Exp. Co., Ltd | China | – | registered |
| ITAS G PHARMA | India | – | registered |
| ITL Health Group | Australia | – | registered |
| Industria Farmeceutica Galenica Senese S.r.l. | Italy | – | registered |
| Inpeco SA Present in Europe in other categories | Italy | – | registered |
| JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD. Present in Europe in other categories | China | – | registered |
| JMS HEALTHCARE PHL, INC. | Philippines | – | registered |
| Joinsmart Biomedical Co., Ltd. | Taiwan | – | registered |
| KMI IMI GROUP / DBA INNOVATIVE MED, INC. | United States | – | registered |
| Kluge Design LLC | United States | – | registered |
| Life Science Outsourcing, Inc. | United States | – | registered |
| Lotus US Bidco Inc. | United States | – | registered |
| MACK MOLDING COMPANY | United States | – | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | – | registered |
| MILLSTONE MEDICAL OUTSOURCING LLC. | United States | – | registered |
| MULTISOURCE MANUFACTURING LLC | United States | – | registered |
| Medtronic Cardiac Surgery | United States | – | K241053 (2024) |
| Medtronic Perfusion Systems | United States | – | K181954 (2018) |
| Miller Technical Services | United States | – | registered |
| Miracell Co.,Ltd. Present in Europe in other categories | South Korea | – | registered |
| NARANG MEDICAL, LTD. Present in Europe in other categories | India | – | registered |
| NICHROMINOX | France | – | registered |
| NOVOSCI CORP. | United States | – | registered |
| Ortosistemas, S.A. | Panama | – | registered |
| P BHOGILAL PVT LTD | India | – | registered |
The 100 most active manufacturers are shown, out of 126.
Didn't find it?
Tell us what you are looking for. Requests show us which categories to add first.