Instruments for functional explorations and therapeutic interventionsCardiology and cardiosurgery instruments
Extra-corporeal circulation instruments
EMDN code Z120502
Manufacturers registered in Europe (EUDAMED) 7
- 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) 39
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 |
|---|---|---|---|
| Terumo Cardiovascular Systems Corporation | United States | Terumo® Advanced Perfusion System 1 Sarns™ Modular Perfusion System 8000 CDI™ Blood Parameter Monitoring System 550 Sarns™ Cardioplegia Set Sarns™ Infusion Line CAPIOX® Holders | K221895 (2023) |
| NOVOSCI CORP. | United States | GOODWIN HEART LINE METHODIST CARDIOPLEGIC ADMIN. SET GOODWIN LUNG LINE EXTENSION LINE W/16 GA MODIFIED NEEDLE LIFEGIFT CARDIOPLEGIC ADMIN SET CARDIOPLEGIA ADMINISTRATION SET | registered |
| Sorin Group Italia S.R.L. Present in Europe in other categories | United States | DATA MASTER Inspire Exchanger Sinergy and Mini Bag CPB DAC Cardiotomy BMR 1900 UTILITY BRACKET | K250150 (2025) |
| Thoratec Laboratories Corp. | United States | CentriMag™ CIRCULAR OXYGENATOR BRACKET LARGE CIRCULAR OXYGENATOR BRACKET SMALL METAL LOCKING FEATURE FOR CENTRIMAG MOTOR SQUARE OXYGENATOR BRACKET CMAG TRANSPORTER, SPARE PART KIT | registered |
| TERUMO CORPORATION Present in Europe in other categories | United States | CAPIOX | registered |
| Med Michigan Holdings, LLC | United States | Surge Cardiovascular Eight Medical | registered |
| Medtronic, Inc. Present in Europe in other categories | United States | Performer™ MYOtherm XP™ ECMOtherm- II™ BIOtherm™ | K240190 (2024) |
| NOVAMED-USA INC. | United States | NOVATEMP | registered |
| GENESEE BIOMEDICAL, INC. | United States | Heart-Chill Cardiac & Phrenic Insulator Heart Chill Cardiac & Phrenic Insulator | registered |
| CHALICE MEDICAL LIMITED Present in Europe in other categories | United Kingdom | CMO8 Adult PMP Oxygenator with Tubing Pack Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator | registered |
| EUROSETS SRL Present in Europe in other categories | Italy | TRILLY HORIZON | registered |
| MICHIGAN CRITICAL CARE CONSULTANTS, INC. | – | MC3 Nautilus Oxygenator Holder VitalFlow Caddy | registered |
| NAVILYST MEDICAL, INC. | United States | Navilyst | registered |
| Avalign Technologies, Inc. | United States | Millennium | registered |
| Daily Medical Products, Inc. | United States | Daily Cardiac Cooling Jacket | K896973 (1990) |
| Gentherm Medical, LLC Present in Europe in other categories | United States | Hemotherm | registered |
| Lifemotion Medical Technology Co., Ltd. | China | Lifemotion | registered |
| QTREX Quantum Ltd. | Israel | INSPIRA CART | registered |
| SANTA BARBARA IMAGING SYSTEMS, INC. Present in Europe in other categories | United States | ZEOS | registered |
| ATRION CORP. | United States | – | registered |
| Abbott Laboratories Present in Europe in other categories | United States | – | registered |
| Century HLM Investments, LLC | United States | – | registered |
| Century Hlm, LLC | United States | – | K202125 (2021) |
| DEROYAL INDUSTRIES, INC. Present in Europe in other categories | United States | – | registered |
| DSV Contract Logistics | Mexico | – | registered |
| FOREMOUNT ENTERPRISE CO., LTD. | Taiwan | – | registered |
| GEISTER MEDIZINTECHN | Germany | – | registered |
| Kluge Design LLC | United States | – | registered |
| LAUDA DR. R. WOBSER GMBH & CO. KG | Germany | – | registered |
| MULTISOURCE MANUFACTURING LLC | United States | – | registered |
| Makar Consulting Pty Ltd | Australia | – | registered |
| MediKomp GmbH | Germany | – | registered |
| Mediyant Technologies Private Limited | India | – | registered |
| NIPRO CORPORATION Present in Europe in other categories | Japan | – | registered |
| QUALITEAM s.r.l. Present in Europe in other categories | Italy | – | registered |
| Quara S.R.L. | Italy | – | K223879 (2023) |
| Qura S.R.L | Italy | – | K220110 (2022) |
| Sechrist Industries, Inc. Present in Europe in other categories | United States | – | K023745 (2003) |
| Tarmetec OU | Estonia | – | registered |
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