Blood bags and kits
EMDN code B01
Manufacturers registered in Europe (EUDAMED) 38
- 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) 76
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 |
|---|---|---|---|
| AEON BIOTHERAPEUTICS CORP. | Taiwan | Aeon CPKit Virtue CPKit Aeon ACKit Virtue ACKit Transcend PRP | registered |
| Changsha Yingtai Instrument Co., Ltd Present in Europe in other categories | China | Yingtai | 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 |
| 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 |
| 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 |
| 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 |
| FIDIA FARMACEUTICI SPA Present in Europe in other categories | Italy | RICHPLAT ORTHO 40 PRP SYSTEM RICHPLAT ORTHO PRP SYSTEM | registered |
| Rmedica Co.,Ltd Present in Europe in other categories | South Korea | Dr.PRP | registered |
| Fresenius Kabi AG Present in Europe in other categories | Germany | CompoSeal Slim | registered |
| GALE FORCE AESTHETICS, LLC | United States | Illuminate PRP | registered |
| ITL ASIA PACIFIC SDN. BHD. Present in Europe in other categories | – | CrocClamp™ (Non-Reopening Clamp) | registered |
| Luvo Medical Technologies, Inc. Present in Europe in other categories | Canada | World PRP | registered |
| ORTHOASCENT, LLC | United States | ASCENT FLEXXPRP | registered |
| 3BY Ltd. | Israel | – | registered |
| AB Elektronik-Konstruktion Innovation (Abelko) | Sweden | – | registered |
| Advanced Molding Technologies | United States | – | registered |
| Andreas Hettich GmbH Present in Europe in other categories | Germany | – | registered |
| B.T.I. BIOTECHNOLOGY | Spain | – | registered |
| Beijing Hanbaihan Medical Devices Co., Ltd. Present in Europe in other categories | China | – | registered |
| Bimini Health Tech Present in Europe in other categories | United States | – | registered |
| Biocells Discoveries Internacional (Biocells) | Ecuador | – | registered |
| Biogenomics S.A.C. - Biocells Surgical | Peru | – | registered |
| Bioprod d.o.o. | Slovenia | – | registered |
| Conroy Medical AB | Sweden | – | registered |
| Crosmed S.A. | Argentina | – | registered |
| Dermaqual | United States | – | registered |
| Evoskin LLC | United States | – | registered |
| Farmaco Quimica Nacional, S.A. | Dominican Republic | – | 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 |
| Guangxi Ehall Medical Technology Co.,Ltd | China | – | registered |
| ITAS G PHARMA | India | – | registered |
| ITL Health Group | Australia | – | registered |
| Industria Farmeceutica Galenica Senese S.r.l. | Italy | – | registered |
| Joinsmart Biomedical Co., Ltd. | Taiwan | – | registered |
| KMI IMI GROUP / DBA INNOVATIVE MED, INC. | United States | – | registered |
| Life Science Outsourcing, Inc. | United States | – | registered |
| MILLSTONE MEDICAL OUTSOURCING LLC. | United States | – | registered |
| NICHROMINOX | France | – | registered |
| Ortosistemas, S.A. | Panama | – | registered |
| Phoenix Medical Products | United States | – | registered |
| QUALITY TECH SERVICES, LLC | United States | – | registered |
| Resolution Medical, LLC | United States | – | registered |
| Roechling Medical Rochester, L.P. | United States | – | registered |
| Shineo Technology CO., LTD. | Taiwan | – | registered |
| Spartronics Watertown LLC | United States | – | registered |
| SpineSmith Holdings,LLC | United States | – | registered |
| Sunphoria Co., Ltd. | Taiwan | – | registered |
| TRIDENT MANUFACTURING, INC. | United States | – | registered |
| Tiger Aesthetics Medical | United States | – | registered |
| Transcend Biologics, LLC | United States | – | registered |
| Tribe Medical Group | Canada | – | registered |
| Vante, Inc. | United States | – | registered |
| Vecmedical Spain, S.L. Present in Europe in other categories | Spain | – | registered |
| Viant Medical, LLC | United States | – | registered |
| ZIEN MEDICAL TECHNOLOGIES, INC. | United States | – | registered |
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