Instruments for functional explorations and therapeutic interventionsCardiology and cardiosurgery instrumentsExtra-corporeal circulation instruments
Extra-corporeal circulation systems
EMDN code Z12050201
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) 18
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 | Cardiovascular Procedure Kit Sarns™ Cardioplegia Set Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. Capiox® SX Hollow Fiber Oxygenator with Hardshell Reservoir NX19 East Sub-Assembly-Japan Only, Export Only | K071521 (2007) |
| Sorin Group Italia S.R.L. Present in Europe in other categories | United States | KIDS INSPIRE Vanguard CSC 14 | K250150 (2025) |
| Medtronic, Inc. Present in Europe in other categories | United States | MYOtherm XP™ ECMOtherm- II™ BIOtherm™ | K240190 (2024) |
| 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 |
| 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 |
| 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 |
| TERUMO CORPORATION Present in Europe in other categories | United States | CAPIOX | registered |
| Thoratec Laboratories Corp. | United States | CentriMag™ | registered |
| ATRION CORP. | United States | – | registered |
| Abbott Laboratories Present in Europe in other categories | United States | – | registered |
| DSV Contract Logistics | Mexico | – | registered |
| LAUDA DR. R. WOBSER GMBH & CO. KG | Germany | – | 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) |
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