Instruments for functional explorations and therapeutic interventionsInstruments to support and monitor vital signs
Infusion instruments
EMDN code Z120303
Manufacturers registered in Europe (EUDAMED) 78
- 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) 167
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) |
| SUMMIT MEDICAL PRODUCTS, INC. Present in Europe in other categories | United States | ambIT Uni-Flo | K162165 (2017) |
| SB-KAWASUMI LABORATORIES, INC. Present in Europe in other categories | Japan | PORT ACCESS INFUSION SET | registered |
| 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 |
| 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) |
| 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 |
| STERIS Corporation Present in Europe in other categories | United States | Amsco | K111870 (2011) |
| ALPHA SOURCE INC. | – | ALPHA SOURCE BATTERY | registered |
| ENTHERMICS, INC. | – | ivNext EC1540BL DC400L MED2428-L MED2226 EC1730BL | 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) |
| 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) |
| Lepu Medical Technology (Beijing) Co., Ltd | China | Angioway | registered |
| SKYTRON LLC | United States | Skytron warming cabinet | registered |
| Beta Bionics, Inc. | United States | iLet Bionic Pancreas iLet Insulin Infusion Kit iLet Connect Adapter 15-Pack (BB3052) iLet Starter Kit - Inset 23" iLet Insulin Infusion Kit – Contact Detach™ (23"", 6mm) - 20-Pack iLet Connect Adapter | K263422 (2026) |
| Tandem Diabetes Care, Inc. Present in Europe in other categories | United States | t:slim Cartridge, t:lock, 10 Pack t:slim X2 Insulin Pump t:slim Cartridge 2 Pack t:slim Insulin Pump, Demonstration t:slim Cartridge 10 Pack t:flex Cartridge, t:lock, 10 Pack | K162080 (2016) |
| Insulet Corporation Present in Europe in other categories | United States | Omnipod Omnipod DASH Pod Omnipod Go Insulin Delivery Device 30U/day Omnipod DASH PDM Omnipod Go Insulin Delivery Device 35U/day Omnipod Go Insulin Delivery Device 10U/day POD | K223372 (2023) |
| INFUTRONIX LLC | – | Nimbus Nimbus II PainPRO Nimbus II EpiD Nimbus II Plus Nimbus II Flex | registered |
| Modular Medical, Inc. | United States | MODD1 Pump PIVOT Insulin Pump Starter Kit PIVOT Insulin Pump Replacement PIVOT Supply Kit (1pk) MMI App for iOS MODD1 Starter Kit | K262153 (2026) |
| United Therapeutics Corporation | – | RemunityPRO | registered |
| 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) |
| MEDOVATE LIMITED Present in Europe in other categories | United Kingdom | SAFIRA | K230083 (2023) |
| The Surgical Company International B.V. | Netherlands | Fluido® AirGuard System Fluido® Compact | K252636 (2025) |
| GENOSS CO., Ltd. | South Korea | GENOSS Inflator B40 GENOSS Inflator B30 | registered |
| 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) |
| 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 |
| Tianck Medical Co., Ltd. Present in Europe in other categories | China | Balloon inflation device | registered |
| Conmed Corporation Present in Europe in other categories | United States | CONMED | 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) |
| 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) |
| Nipro Vascular Innovations Americas, Inc. | United States | GM-30 Accessory Kit GM-30 Inflation Device | registered |
| BLUEFIN MEDICAL LLC | – | Hands Free Syringe | registered |
| CEQUR CORPORATION | United States | CeQur Simplicity | registered |
| CONCERT MEDICAL, LLC | United States | Hands Free Syringe | K153599 (2016) |
| MANNKIND CORPORATION | United States | V-Go Disposable Insulin Delivery | registered |
| 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) |
| Femasys, Inc. | United States | StopLock VariLock | registered |
| 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 |
| American I.V. Products, Inc. | United States | AIV | K032789 (2003) |
| Atlanta BioMedical Corporation | United States | Atlanta BioMedical Model 4100 | registered |
| Biegler GmbH | United States | Extension Set Blood and Infusion Warmer | K121198 (2012) |
| Covidien, LLC Present in Europe in other categories | United States | ClosureFast | registered |
| MEDICAL DEVICE RESOURCE CORPORATION | United States | MD Resource | registered |
| MEDICAL TECHNOLOGY PRODUCTS INC | – | MTP | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | NAMIC | registered |
| Wells Johnson Co. | United States | Wells Johnson Infusion System (WIS) Wells Johnson HVP System | K991437 (1999) |
| 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) |
| Sunny Medical Device (Shenzhen) Co., Ltd. | United States | Sunmed Inflation Device Sunmed Inflation Device | registered |
| ADVANCED INSTRUMENTATIONS, INC. | United States | ADVANCED INFUSION PUMP | registered |
| Boston Scientific Corp Present in Europe in other categories | United States | Encore 26 | registered |
| EMIT CORPORATION | United States | HypothermX HX100 Intravenous Fluid and Blood Warmer HypothermX LG Intravenous Fluid and Blood Warmer | K103801 (2011) |
| 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 |
| 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 |
| Scpharmaceuticals Inc. | – | On-body Infusor for Furoscix® | registered |
| VYAIRE MEDICAL, INC. Present in Europe in other categories | United States | enFlow™ enFlow | registered |
| WALKMED TECHNOLOGIES, LLC | United States | WalkMed® | registered |
| Barkey GmbH & Co. KG Present in Europe in other categories | Germany | Barkey S-line | K213191 (2022) |
| Elite Medtek (Jiangsu) Co., Ltd. | China | Elite Medtek | registered |
| Jiangsu Vedkang Medical Science and Technology Co.,Ltd. Present in Europe in other categories | China | Balloon Inflators | registered |
| Micro-Tech (Nanjing) Co., Ltd. | China | Disposable Inflation Device | registered |
| US Endoscopy | United States | Lumiflex | registered |
| A/S Kurt Hansen | Denmark | – | registered |
| ADVANCE TECHNOLOGY LTD | China | – | registered |
| ADVANCED SCIENTIFICS, INC. | United States | – | registered |
| AIM B.V. | Netherlands | – | registered |
| ATRION CORP. | United States | – | registered |
| Amphenol Critical Medical Technologies, LLC | United States | – | registered |
| BMR Medical | Brazil | – | registered |
| BOEN HEALTHCARE CO., LTD. Present in Europe in other categories | China | – | 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 |
| Brun Medical Co., Ltd. | China | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| COMMAND MEDICAL PRODUCTS, LLC | United States | – | registered |
| Changzhou Jiuhong Medical Instrument Co., Ltd. Present in Europe in other categories | China | – | registered |
| Clarity Design Inc | United States | – | registered |
| Deka R&D Corp | United States | – | K253703 (2026) |
| Deka Research and Development | United States | – | K261672 (2026) |
| Dongguan Honfield Precision Parts Co., Ltd | China | – | registered |
| ECM Europe BV | Netherlands | – | registered |
| ENERCON TECHNOLOGIES | United States | – | registered |
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