Instruments for functional explorations and therapeutic interventionsInstruments to support and monitor vital signsInfusion instruments
Infusion pumps
EMDN code Z12030301
Manufacturers registered in Europe (EUDAMED) 51
- 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 |
|---|---|---|---|---|
| Medcaptain FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | IIb MDR, 93/42 | Website info@medcaptain.com EUDAMED record Report an error | |
| Daiwha EU representative : mdi Europa GmbH (Germany) | South Korea |
1 other |
IIb 93/42 | Website info@daiwha.com EUDAMED record Report an error |
| Hunan Beyond Medical Technology FDA EU representative : Wellkang Ltd (Northern Ireland) | China |
1 other |
IIb 93/42 | Website sale@csbeyond.com EUDAMED record Report an error |
| Sino Medical-Device Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | IIb 93/42 | EUDAMED record Report an error | |
| Akas Medical Equipment EU representative : Amstermed B.V. (Netherlands) | India | IIb 93/42 | Website EUDAMED record Report an error | |
| Brosmed FDA EU representative : Brosmed Medical B.V. (Netherlands) | China | I 93/42 | Website EUDAMED record Report an error | |
| Hawkmedical EU representative : Umedwings Netherlands B.V. (Netherlands) | China |
|
IIb MDR, 93/42 | EUDAMED record Report an error |
| Hedymed EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China |
|
IIb 93/42 | Website EUDAMED record Report an error |
| Medrena EU representative : SUNGO Europe B.V. (Netherlands) | China | IIb MDR, 93/42 | sales@medrena.com EUDAMED record Report an error | |
| Nouvag FDA EU representative : Nouvag GmbH (Germany) | Switzerland |
|
IIa 93/42 | Website EUDAMED record Report an error |
| Shenzhen Comen Medical Instruments FDA EU representative : Lotus NL B.V. (Netherlands) | China |
|
IIb MDR, 93/42 | EUDAMED record Report an error |
| Sooil FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) | South Korea |
|
IIb 93/42 | Website EUDAMED record Report an error |
| Dixion | Germany | IIb MDR | Website info@dixion.de EUDAMED record Report an error | |
| EMED Technologies FDA EU representative : Emergo Europe B.V. (Netherlands) | United States |
|
IIa 93/42 | Website customerservice@emedtc.com EUDAMED record Report an error |
| Shenzhen Enmind Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | IIb MDR, 93/42 | EUDAMED record Report an error | |
| Vennermedical FDA | Germany |
|
IIb 93/42 | Website info@vennermedical.de EUDAMED record Report an error |
| Zerone EU representative : CMC Medical Devices & Drugs SL (Spain) | South Korea | IIb 93/42 | Website EUDAMED record Report an error | |
| Ampall EU representative : AR Experts B.V. (Netherlands) | South Korea |
|
IIb 93/42 | Website EUDAMED record Report an error |
| Bbraun FDA | Germany | IIb MDR | Website eudamed@bbraun.com EUDAMED record Report an error | |
| France Développement Electronique | France | IIb MDR | Website qualite@fde.fr EUDAMED record Report an error | |
| Guangdong Biolight Meditech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | IIb MDR | Website EUDAMED record Report an error | |
| Hologic FDA EU representative : Hologic BV (Belgium) | United States | IIb MDR, 93/42 | EUDAMED record Report an error | |
| Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | IIb MDR | EUDAMED record Report an error | |
| Nobamedi EU representative : JaviTech e.K. (Germany) | South Korea |
|
IIb 93/42 | Website contact@nobamedi.com EUDAMED record Report an error |
| SQ Innovation EU representative : AR Experts B.V. (Netherlands) | United States | IIb MDR | Website info@sqinnovation.com EUDAMED record Report an error | |
| Terumo FDA EU representative : TERUMO EUROPE N.V. (Belgium) | Japan |
|
IIb 93/42 | Eudamed_LAA@terumo.co.jp EUDAMED record Report an error |
| Abbott FDA EU representative : Abbott Medical (Belgium) | United States | IIb MDR | EUDAMEDInq_EP@abbott.com EUDAMED record Report an error | |
| Apex Medical FDA EU representative : SciPharm Sàrl (Luxembourg) | China | IIb 93/42 | Website info@apexdiabetes.com EUDAMED record Report an error | |
| Baxter FDA EU representative : Baxter Deutschland GmbH (Germany) | Switzerland |
|
IIb MDR | Website EUDAMED record Report an error |
| Bayer FDA EU representative : Bayer Medical Care B.V. (Netherlands) | United States | IIb MDR | EUDAMED record Report an error | |
| Bd FDA EU representative : Becton Dickinson Ireland Limited (Ireland) | Switzerland |
|
IIb 93/42 | Website EUDAMEDenquiries@bd.com EUDAMED record Report an error |
| Beijing KellyMed EU representative : Umedwings Netherlands B.V. (Netherlands) | China |
|
IIb MDR | Website EUDAMED record Report an error |
| Biosense Webster FDA EU representative : Biosense Webster A Division of Johnson & Johnson Medical NV/SA (Belgium) | United States | IIa MDR | EUDAMED_Enquiries@its.jnj.com EUDAMED record Report an error | |
| Bracco FDA EU representative : ACIST Europe BV (Netherlands) | United States | IIb 93/42 | Services.ProfessionalEurope@bracco.com EUDAMED record Report an error | |
| Bssmedikal | Türkiye | IIb 93/42 | Website info@bssmedikal.com EUDAMED record Report an error | |
| Caesarea Medical Electronics EU representative : Becton Dickinson Ireland Limited (Ireland) | Israel |
|
IIb 93/42 | EUDAMEDenquiries@bd.com EUDAMED record Report an error |
| Codan Argus EU representative : CODAN pvb Critical Care GmbH (Germany) | Switzerland |
|
IIb MDR | Website regulatory@codanargus.com EUDAMED record Report an error |
| Contecmed FDA EU representative : Prolinx GmbH (Germany) | China | IIb MDR | Website pms.qms@contecmed.com EUDAMED record Report an error | |
| Eitan Medical FDA EU representative : MedNet EC-REP IIb GmbH (Germany) | Israel | IIb MDR | support@eitanmedical.com EUDAMED record Report an error | |
| Everaid FDA EU representative : Ferrer Internacional, S.A. (Spain) | South Korea |
|
IIb 93/42 | EUDAMED record Report an error |
| Fresenius Kabi FDA | Germany |
|
IIb MDR | Website EUDAMED-FK@fresenius-kabi.com EUDAMED record Report an error |
| Hepho EU representative : R Sight B.V. (Netherlands) | China |
|
IIb 93/42 | EUDAMED record Report an error |
| Inreda Diabetic | Netherlands |
|
IIb MDR | Website eudamedinfo@inredadiabetic.nl EUDAMED record Report an error |
| Medsure Medical Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | IIb MDR | EUDAMED record Report an error | |
| Medtronic FDA EU representative : Medtronic B.V. (Netherlands) | United States | IIa MDR | EUDAMED record Report an error | |
| Micrelmed | Greece |
|
IIb 93/42 | Website info@micrelmed.com EUDAMED record Report an error |
| Progetti | Italy |
|
IIb 93/42 | Website info@progettimedical.com EUDAMED record Report an error |
| Smisson-Cartledge Biomedical FDA EU representative : Emergo Europe B.V. (Netherlands) | United States | IIa, IIb MDR | EUDAMED record Report an error | |
| Witmedica EU representative : CMC Medical Devices & Drugs SL (Spain) | China |
|
IIb 93/42 | Website sales@witmedical.com EUDAMED record Report an error |
| Wooyoungmed FDA EU representative : Obelis s.a. (Belgium) | South Korea |
|
IIb 93/42 | EUDAMED record Report an error |
| Alliedmed FDA EU representative : AR Experts B.V. (Netherlands) No model still on the market | India |
|
IIb 93/42 | Website sales@alliedmed.co.in 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) 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 |
|---|---|---|---|
| PEDIGO PRODUCTS, INC. | United States | Pedigo Products, Inc. | registered |
| ICU MEDICAL, INC. Present in Europe in other categories | United States | Plum 360 CADD Medfusion Graseby PharmGuard | K262532 (2026) |
| Go Medical Industries Pty. , Ltd. | Australia | Flow Control Tubing Springfusor | K910007 (1993) |
| STERIS Corporation Present in Europe in other categories | United States | Amsco | K111870 (2011) |
| Belmont Instrument Corp. | United States | 3-Spike Disposable Set (1 Piece) Dual Patient Line Rapid Infuser RI-2, 120V, 1000ml/min 3.0 Liter Reservoir (1 Piece) Patient Line Extension (1 Piece) 3.0 Liter Reservoir (6 Count) | K152208 (2015) |
| Zevex, Inc. Present in Europe in other categories | United States | Curlin Administration Set Curlin Curlin IV Pump System | K242660 (2024) |
| ENTHERMICS, INC. | – | ivNext EC1540BL DC400L MED2428-L MED2226 EC1730BL | registered |
| SB-KAWASUMI LABORATORIES, INC. Present in Europe in other categories | Japan | PORT ACCESS INFUSION SET | registered |
| SUMMIT MEDICAL PRODUCTS, INC. Present in Europe in other categories | United States | ambIT Uni-Flo | registered |
| Quality IN Flow , Ltd. Present in Europe in other categories | Israel | QinFlow Warrior Lite set with 2 Lite Extra Power Battery QinFlow Blood and Fluid Warmer QiF-01 Base Unit (BU) QinFlow portable warmer system QINFLOW WARRIOR HYBRID EXTENDED SET QinFlow Warrior Extreme Blood and Fluid Warmer Base Unit (BU) Warrior EXTREME Hybrid Extended Set | K211800 (2022) |
| Repro-Med Systems, Inc. | United States | RMS Precision Flow Rate TubingTM KORU FREEDOM60® FreedomEdgeTM HIgH-Flo™, RMS Precision Flow Rate TubingTM | K933652 (1994) |
| Rex Pj Tech LLC | – | Beeline motIV | registered |
| SKYTRON LLC | United States | Skytron warming cabinet | registered |
| ALPHA SOURCE INC. | – | ALPHA SOURCE BATTERY | registered |
| Avanos Medical, Inc. | United States | ambiT® "PreSet" Ambulatory Infusion Pump ambIT* PIB*IL Pump ambIT* Cassette - Filter, Male Neuraxial Connector ambIT* PIB-PCA v1.5 System w/Male Filter Cass ambIT* DISPOSABLE PLUS ambIT* PIB/PCA Pump V1.5 | registered |
| Iradimed Corporation | United States | Iradimed | K242752 (2025) |
| Carefusion 303, Inc. | United States | BD® Alaris™ PCU Model 8015 BD Alaris™ PCU Module, Model 8015 Alaris Alaris™ PCA Module, Model 8120 BD Alaris™ Syringe Module, Model 8110 Alaris™ Syringe Module, Model 8110 | K243855 (2025) |
| Imperial Surgical Ltd | Canada | Warming Cabinet Single Compartment Counter-Top Model (Glass Door) Warming Cabinet Single Compartment (Glass Door) Warming Cabinet Single Compartment (SS Door) Warming Cabinet Double Compartment (Glass Door) Warming Cabinet Double Compartment (SS Door) HugAire 2 Cu.Ft.Single Compartment Warming Cabinet | K112702 (2012) |
| The Surgical Company International B.V. | Netherlands | Fluido® AirGuard System Fluido® Compact | K252636 (2025) |
| Stihler Electronic GmbH Present in Europe in other categories | Germany | ASTOFLO® PLUS ECO | K082765 (2008) |
| NORTH AMERICAN RESCUE, LLC | United States | NAR Life Warmer Quantum Blood and Fluid Warming System Life Warmer Quantum Charger Life Warmer Quantum Thermal Infusion Set (TIS) Life Warmer Quantum Thermal Transfusion Set for Blood and Blood Products (TTS-B) Life Warmer Quantum Blood and Fluid Warming System (IV Fluid ONLY Configuration) | registered |
| Mequ A/S | Denmark | °M Warmer System - °M Station °M Warmer System - Starter Kit+ °M Warmer System - Power Pack+ °M Warmer System - Starter Kit °M Warmer System - Charger °M Warmer System - °M Warmer | K260988 (2026) |
| Cane S.R.L. Present in Europe in other categories | United States | crn CRONO Syringe reservoir Crono APO-GO Syringe reservoir | K091042 (2009) |
| United Therapeutics Corporation | – | RemunityPRO | registered |
| Cardinal Health, Inc. Present in Europe in other categories | United States | Kangaroo | registered |
| INFUTRONIX LLC | – | Nimbus Nimbus II PainPRO Nimbus II EpiD Nimbus II Plus Nimbus II Flex | registered |
| MEDOVATE LIMITED Present in Europe in other categories | United Kingdom | SAFIRA | K230083 (2023) |
| HK SURGICAL INC. | United States | HK Klein TDD Pump Klein Tumescent Infiltration Pump HK Klein Infiltration Pump+ Klein Infiltration Pump II Klein Touch Pump | K123822 (2013) |
| Smithworks, Inc. | United States | Smithworks Medical, Inc. Smithworks Medical Inc. Smithworks Medical, Inc | K060851 (2006) |
| Thermedx, LLC | United States | Fluid Management System Urology Set Tubing Set - Single Lumen, Inflow with Dual Outflow Luer Lock Set, Single Lumen | registered |
| Airlife, Inc. | United States | enFlow™ | registered |
| Biegler GmbH | United States | Extension Set Blood and Infusion Warmer | K121198 (2012) |
| Conmed Corporation Present in Europe in other categories | United States | CONMED | registered |
| Milestone Scientific Inc. Present in Europe in other categories | United States | Epidural Disposable Kit Epidural Trainer Disposable Kit CompuFlo Epidural Trainer 110V/220V | K053554 (2006) |
| Zyno Medical, LLC | United States | Z-800 Z-800F Z-800W Z-800WF | K153193 (2016) |
| BLUEFIN MEDICAL LLC | – | Hands Free Syringe | registered |
| CONCERT MEDICAL, LLC | United States | Hands Free Syringe | K153599 (2016) |
| Estill Medical Technologies, Inc. | United States | Thermal Angel Ultra Battery 1 Thermal Angel TA-UPC Ultra Power Cable 3' | registered |
| Medela AG Present in Europe in other categories | Switzerland | Enteral Feeding | registered |
| Nxstage Medical, Inc. | United States | COMFORTMATE FLUID WARMER DISPOSABLE COMFORTMATE FLUID WARMER | K012832 (2001) |
| Rand S.R.L. Present in Europe in other categories | Italy | Hang&Go HT Basic Performer HT Hang&Go PAC | K161613 (2016) |
| Smith & Nephew, Inc. Present in Europe in other categories | United States | Intellijet | K020947 (2002) |
| ZOLL Medical Corporation Present in Europe in other categories | United States | Power Infuser | K172653 (2018) |
| American I.V. Products, Inc. | United States | AIV | K032789 (2003) |
| Atlanta BioMedical Corporation | United States | Atlanta BioMedical Model 4100 | registered |
| Covidien, LLC Present in Europe in other categories | United States | ClosureFast | registered |
| EMIT CORPORATION | United States | HypothermX HX100 Intravenous Fluid and Blood Warmer HypothermX LG Intravenous Fluid and Blood Warmer | K103801 (2011) |
| MEDICAL DEVICE RESOURCE CORPORATION | United States | MD Resource | registered |
| MEDICAL TECHNOLOGY PRODUCTS INC | – | MTP | registered |
| Phillips-Medisize A/S Present in Europe in other categories | United States | VYAFUSER™ | registered |
| STRYKER CORPORATION Present in Europe in other categories | United States | ThermaClear | registered |
| VYAIRE MEDICAL, INC. Present in Europe in other categories | United States | enFlow™ enFlow | registered |
| Wells Johnson Co. | United States | Wells Johnson Infusion System (WIS) Wells Johnson HVP System | K991437 (1999) |
| ADVANCED INSTRUMENTATIONS, INC. | United States | ADVANCED INFUSION PUMP | registered |
| Barkey GmbH & Co. KG Present in Europe in other categories | Germany | Barkey S-line | K213191 (2022) |
| Haemonetics Corp. Present in Europe in other categories | United States | HAEMONETICS R.I.S. SYSTEM | K860969 (1986) |
| Innovative Med | United States | K-Pump | registered |
| Mettler Electronics Corp. | United States | Silberg T.P.S. | K023083 (2003) |
| OPTUMHEALTH CARE SOLUTIONS, INC. | Canada | Zyno Solutions | registered |
| Optum Distribution Center, LLC | – | Avoset Optum Homecare Infusion | registered |
| Scpharmaceuticals Inc. | – | On-body Infusor for Furoscix® | registered |
| WALKMED TECHNOLOGIES, LLC | United States | WalkMed® | registered |
| A/S Kurt Hansen | Denmark | – | registered |
| ADVANCED SCIENTIFICS, INC. | United States | – | registered |
| AIM B.V. | Netherlands | – | registered |
| Amphenol Critical Medical Technologies, LLC | United States | – | registered |
| BMR Medical | Brazil | – | registered |
| Becton, Dickinson & CO Present in Europe in other categories | United States | – | registered |
| Beldico S.A. | Belgium | – | registered |
| Belmont Medical Technologies Present in Europe in other categories | United States | – | K242735 (2024) |
| Blue Ocean Innovation Limited | Hong Kong SAR China | – | registered |
| Bo-Mer Plastics | United States | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| COMMAND MEDICAL PRODUCTS, LLC | United States | – | registered |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | – | registered |
| Clarity Design Inc | United States | – | registered |
| Deka R&D Corp | United States | – | K253703 (2026) |
| Deka Research and Development | United States | – | K250357 (2025) |
| Dongguan Honfield Precision Parts Co., Ltd | China | – | registered |
| ECM Europe BV | Netherlands | – | registered |
| ENERCON TECHNOLOGIES | United States | – | registered |
| Emsere, Inc | Netherlands | – | registered |
| FRESENIUS MEDICAL CARE Present in Europe in other categories | Germany | – | registered |
| Flextronics International USA, Inc. | United States | – | registered |
| Garrett Heilbrun Technology Partners, LLC dba Cobalt Product | United States | – | registered |
| HEALTHCARE TECHNOLOGY INTERNATIONAL LTD. | Hong Kong SAR China | – | registered |
| Hennig Enterprises Europe Srl | Australia | – | registered |
| Hospira, Inc. | United States | – | K161469 (2017) |
| INTRICON CORPORATION | United States | – | registered |
| Innovative Health Sciences | United States | – | registered |
| Ivenix, Inc. | United States | – | K183311 (2019) |
| Koru Medical Systems, Inc. | United States | – | K252015 (2026) |
| Life Warmer, Inc. | United States | – | K192325 (2019) |
| M.A.C. MEDICAL INC. | United States | – | K180842 (2019) |
| MFG ONE, LLC | United States | – | registered |
| MOOG, INC. | United States | – | registered |
| Maya Medical Top Trade Ltd. | Israel | – | registered |
| Medical Solutions, Inc. | United States | – | K041839 (2005) |
| Medicar Health Inc. | United States | – | registered |
| Meditera Tibbi Malzeme Sanayi ve Ticaret A.S. | Türkiye | – | registered |
The 100 most active manufacturers are shown, out of 126.
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