IVD instrumentsSample processing systems
Various sample processing instruments
EMDN code W020690
Manufacturers registered in Europe (EUDAMED) 71
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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Other manufacturers known in the United States (FDA) 181
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 |
|---|---|---|---|
| Thermo Electron LED GmbH | – | Thermo Scientific Fisher Scientific Cardinal Fisherbrand | registered |
| Agilent Technologies, Inc. Present in Europe in other categories | United States | MFXP2R-SI ELx405VS-SI 406PSUB3LB-SI 406PSU0LB-SI 405TSHT-SI 405TSUSQ-SI | registered |
| LW SCIENTIFIC, INC. | United States | LW Scientific, Inc. E8 Combination Centrifuge, digital E8 Combination Centrifuge, fixed speed E8 Combination Centrifuge, variable speed MX12 Centrifuge with 24-place hematocrit rotor Zip-IQ Digital Hematocrit Centrifuge | registered |
| Caliper Life Sciences, Inc. | – | JANUS G3 Fontus JANUS G3 Blood iQ Janus G3 Automated Workstation JANUS G3 NGS Express | registered |
| Precision Systems, Inc. | United States | Multi-OSMETTE OSMETTE Sample Tubes, 30 ul OSMETTE XL Micro-OSMETTE OSMETTE III OSMETTE A | registered |
| Arteriocyte Medical Systems, Inc. Present in Europe in other categories | United States | Magellan Autologous Platelet Separator System Magellan Aspiration kit Magellan Complete One Source Kit Magellan Complete Disposable Kit Magellan Surgical tools for erythrocyte & marrow preparation kit | registered |
| CAPlugs Present in Europe in other categories | United States | Caplugs/Evergreen | registered |
| EMCYTE CORP. | United States | Accelerate Platelet Concentrating System PRP-S 30mL Accelerate II Platelet Concentrating System PRP-S 30mL Accelerate II Platelet Concentrating System PRP-S 60mL AbsolutePRP 60mL GenesisCS Component Concentrating System PurePRP II 60mL GenesisCS Component Concentrating System PureBMC-120mL GenesisCS Component Concentrating System | K183205 (2019) |
| Celling Biosciences | – | ART BMC System Centrifuge Celling ART BMC System Celling ART BMC Plus Celling ART BMC | registered |
| RICHARD-ALLAN SCIENTIFIC COMPANY Present in Europe in other categories | – | Epredia | registered |
| Biobase Biodustry(Shandong)Co., Ltd. | China | BIOBASE | registered |
| Tecan U.S., Ltd. Present in Europe in other categories | United States | Freedom EVO® Fluent® Freedom EVO 75 Veya Dx 6 Veya Dx 9 | K953345 (1995) |
| ABBOTT MOLECULAR INC. Present in Europe in other categories | United States | Alinity mp Alinity m | registered |
| Fisher Scientific Co., LLC | United States | Fisherbrand | registered |
| Roche Molecular Systems, Inc. | United States | cobas® prime Pre-analytical System AVENIO Edge System cobas® prime Secondary Tube Tray AcfS Library Robot cobas® prime Tip Rack Tray cobas® prime User Workflow Reagent Bottle | registered |
| Dynarex Corporation | United States | LabChoice Centrifuge Tubes, Polypropylene, 50 ML, Sterile LabChoice Centrifuge Tubes, Polypropylene, 50ML LabChoice Microcentrifuge Tubes, Polypropylene, 2mL, Sterile LabChoice Centrifuge Tubes, Polypropylene LabChoice Centrifuge Tubes, Polypropylene, 50 ML LabChoice Microcentrifuge Tubes, Polypropylene, 1.5mL, Sterile | registered |
| Helena Laboratories | United States | Super Z Applicator (8-sample) Electrophoresis Handler, CE Version ESH, "CE", (New Computer) QuickGel Applicator Super Z 12-Applicator (12-sample) ESH, "CE", (New Pump) | K862701 (1986) |
| APEX BIOLOGIX , LLC | United States | XCELL | registered |
| ARTHREX, INC. Present in Europe in other categories | United States | Arthrex® | registered |
| Biomet Biologics, LLC | – | BioCUE® BioCUE® Mini Concentration System BioCUE® Concentration System Plasmax® Counterbalance Plasmax® Plus Counterbalance | registered |
| EUROIMMUN Medizinische Labordiagnostika AG Present in Europe in other categories | Germany | EUROBlotMaster EUROBlotMaster 44 EUROLabWorkstation IFA IF Sprinter UNIQO 160 Sprinter XL | registered |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein | registered |
| SEPARATION TECHNOLOGY, INC. | United States | HemataSTAT II Centrifuge HemataSTAT II Centrifuge (Refurbished) Tube Sealant, Hemataseal Transparent Disp. Tube Tolders (for HemataSTAT, Cream 50/pkg) 3D Printed Disp. Tube Holders (for HemataSTAT, Cream 50/pkg) | K913128 (1991) |
| Becton, Dickinson & CO Present in Europe in other categories | United States | BD MicroProbe™ Processor BD FACS™ FACS | K023955 (2003) |
| Biosafe Laboratories, Inc. | United States | Sepax single-use kit Separation Chamber Holder Sepax RM Regenerative medicine-Single-use kits | registered |
| DYNEX TECHNOLOGIES, INC. Present in Europe in other categories | United States | DYNEX DS2 DYNEX DSX DYNEX Agility DIALISA 2MP | registered |
| Lifehealth | – | CC Cartridge H3 Cartridge H4 Cartridge | registered |
| Thermogenesis Corp. Present in Europe in other categories | United States | MXP Processing Bagset MXP Docking Station MXP Device MXP Start Up Kit Thermogenesis Start Up Accessory Kit, MarrowXpress | K081345 (2008) |
| Zhejiang Biorear Biotechnology Co., Ltd. Present in Europe in other categories | China | Quaero | registered |
| HBH BIOTECHNOLOGY LIMITED Present in Europe in other categories | China | – | registered |
| MEDTOX DIAGNOSTICS, INC. | United States | Torq TrueSpin | registered |
| Alltrista Plastics LLC Present in Europe in other categories | United States | Kova Plastics | registered |
| Bio-Rad Present in Europe in other categories | United States | PhD lx | K900775 (1990) |
| COPAN WASP SRL Present in Europe in other categories | Italy | UniVerse® URIVerse™ External Loader - Turn Table | registered |
| Reapplix ApS | Denmark | 3CP™ Counterbalance 3CP™ Centrifuge Kit 3CP™ Centrifuge | registered |
| SAKURA FINETEK U.S.A., INC. Present in Europe in other categories | United States | Cyto-Tek® 2500 | registered |
| UNITED PRODUCTS & INSTRUMENTS | United States | UNICO POWERSPIN BX UNICO | registered |
| Baebies, Inc. | United States | FINDER | registered |
| Biomet Orthopedics, LLC Present in Europe in other categories | United States | Biomet® | registered |
| Hamilton Bonaduz AG | Switzerland | STAR COMPL. WITH ACCESS. STARLET COMPL. WITH ACCESS. | registered |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| ORTHOASCENT, LLC | United States | BMC Device Masterpack ASCENT FLEXXBMC | registered |
| VISIA LAB SRL Present in Europe in other categories | Italy | dIFine P15 dIFine P30 | registered |
| Zhuhai Longtime Biological Technology Co., Ltd | China | LT Medical Centrifuge for PRP | registered |
| BIOTECHNOLOGY INSTITUTE SL | – | ENDORET SYSTEM V CENTRIFUGE | registered |
| Babson Diagnostics, Inc. | United States | Babson Sample Preparation Device | registered |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| Diagnostic Automation, Inc. | – | Diagnostic Automation, Inc. | registered |
| Exact Sciences Corporation Present in Europe in other categories | United States | Cologuard Capture Aspirator | registered |
| Fresenius Kabi AG Present in Europe in other categories | Germany | Alyx Cart | registered |
| GF HEALTH PRODUCTS, INC. Present in Europe in other categories | United States | Grafco | registered |
| Global Life Sciences Solutions USA LLC | United States | Pall ORO Gas Line Filter | registered |
| Hologic, Inc. Present in Europe in other categories | United States | Tomcat® | registered |
| Ingeneron, Inc. | United States | Tissue Processing Unit | registered |
| KOVA INTERNATIONAL, INC. | – | KOVA | registered |
| Kolplast C I | Brazil | CELLPRESERV KOLPLAST | registered |
| Life PRP, LLC | – | Life PRP LLC | registered |
| MARKETLAB INC. | United States | Marketlab | registered |
| Nuo Therapeutics, Inc. | United States | Aurix Wound Dressing Kit | registered |
| Pall International Sàrl Present in Europe in other categories | United States | Pall® Oxygenator Gas Line Filter | registered |
| QIAGEN GmbH Present in Europe in other categories | Germany | Rapid Capture System | registered |
| T AESTHETICS LLC | – | Nextgen Centrifuge | registered |
| VELA OPERATIONS SINGAPORE PTE. LTD. Present in Europe in other categories | Singapore | Sentosa SX101 | registered |
| AIKEN CORP. | United States | – | registered |
| ANJI SPENQ INDUSTRIAL CO., LTD. | China | – | registered |
| ASP Tiger, LLc | United States | – | registered |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | – | registered |
| Abbott Laboratories Present in Europe in other categories | United States | – | K897158 (1990) |
| Accumax Lab Devices Pvt Ltd | India | – | registered |
| Accuster Technologies Pvt. Ltd. | India | – | registered |
| Advanced Engineering, Inc. | United States | – | registered |
| Advanced Molding Technologies | United States | – | registered |
| Aesthetic expert laboratory | United States | – | registered |
| Amphenol Critical Medical Technologies, LLC | United States | – | registered |
| Apacor Limited | United Kingdom | – | registered |
| Apothecaries Sundries Mfg Pvt Ltd | India | – | registered |
| B.T.I. BIOTECHNOLOGY | Spain | – | registered |
| BOEN HEALTHCARE CO., LTD. Present in Europe in other categories | China | – | registered |
| BRAIN NAVI BIOTECHNOLOGY CO., LTD. Present in Europe in other categories | Taiwan | – | registered |
| Beijing Hanbaihan Medical Devices Co., Ltd. Present in Europe in other categories | China | – | registered |
| BioMed Plastic Co Ltd | China | – | registered |
| Biocells Discoveries Internacional (Biocells) | Ecuador | – | registered |
| Bioteke Corporation (Wuxi) Co., Ltd. Present in Europe in other categories | China | – | registered |
| CG Bio Co., Ltd. | South Korea | – | registered |
| CHARTER MEDICAL, LLC. | United States | – | registered |
| CITOTEST LABWARE MANUFACTURING CO., LTD. Present in Europe in other categories | China | – | registered |
| COPAN ITALIA SPA Present in Europe in other categories | Italy | – | registered |
| CalibreScientific US, Inc. Present in Europe in other categories | United States | – | registered |
| CellSolutions LLC Present in Europe in other categories | United States | – | registered |
| Citotest Scientific Co.,Ltd. Present in Europe in other categories | China | – | registered |
| Clear Labs, Inc | United States | – | registered |
| Cogmedix, Inc. | United States | – | registered |
| D&K Engineering | United States | – | registered |
| DIGISYSTEM LABORATORY INSTRUMENTS INC. | Taiwan | – | registered |
| Device Innovation Company Limited | Thailand | – | registered |
| DiaTrust Medical Co., Ltd. Present in Europe in other categories | China | – | registered |
| Diagnostic Automation /Cortez Diagnostics Inc. | United States | – | registered |
| Dlab Scientific Malaysia SDN.BHD | Malaysia | – | registered |
| Dynamic Devices | United States | – | registered |
| ENDONEST MEDICAL SYSTEMS LLP | India | – | registered |
The 100 most active manufacturers are shown, out of 181.
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