Instruments for functional explorations and therapeutic interventionsCardiology and cardiosurgery instrumentsExtra-corporeal circulation instruments
Extra-corporeal circulation instruments - hardware accessories
EMDN code Z12050280
Manufacturers registered in Europe (EUDAMED) 3
- 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 |
|---|---|---|---|---|
| Maquet Cardiopulmonary FDA | Germany |
14 others
|
I, IIb MDR, 93/42 | raop.cp@getinge.com EUDAMED record Report an error |
| Eurosets FDA | Italy | I, IIb MDR | Website EUDAMED record Report an error | |
| Spectrum Medical FDA EU representative : Spectrum Medical S.r.l. (Italy) | United Kingdom (ex Northern Ireland) | I MDR | Website regulatory@spectrummedical.com 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) 32
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 |
|---|---|---|---|
| LIVANOVA USA, INC. Present in Europe in other categories | Germany | Bracket Forceps Orthofuser Tubing Organizer ESSENZ Venous Line Clamp | K232291 (2023) |
| 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 | CONNECTOR, Y 1/2" X 1/2" X 1/2" W/OUT LUER CONNECTOR, Y 3/16" X 3/16" X 1/4" W/LUER CONNECTOR, 1/2" X 1/2" W/OUT PART LINE CONNECTOR, Y 3/8" X 3/8" X 1/4" W/OUT LUER CONNECTOR, Y 3/8" X 3/8" X 3/8" W/OUT LUER FILTER, GAS/OXYGEN | registered |
| 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 |
| 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 | K103762 (2011) |
| CARDIOQUIP, LLC Present in Europe in other categories | United States | VivaCart Cardio Quip VivaCart Short Infusion Pole with Removable Hooks | registered |
| TERUMO CORPORATION Present in Europe in other categories | United States | CAPIOX | registered |
| Med Michigan Holdings, LLC | United States | Surge Cardiovascular Eight Medical | registered |
| NOVAMED-USA INC. | United States | NOVATEMP | registered |
| MICHIGAN CRITICAL CARE CONSULTANTS, INC. | – | MC3 Nautilus Oxygenator Holder VitalFlow Caddy | registered |
| Medtronic, Inc. Present in Europe in other categories | United States | Performer™ | registered |
| NAVILYST MEDICAL, INC. | United States | Navilyst | registered |
| Avalign Technologies, Inc. | United States | Millennium | 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 |
| Abbott Laboratories Present in Europe in other categories | United States | – | registered |
| CHALICE MEDICAL LIMITED Present in Europe in other categories | United Kingdom | – | 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 |
| FOREMOUNT ENTERPRISE CO., LTD. | Taiwan | – | registered |
| GEISTER MEDIZINTECHN | Germany | – | registered |
| Kluge Design LLC | United States | – | 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 |
| Sechrist Industries, Inc. Present in Europe in other categories | United States | – | K023745 (2003) |
| Tarmetec OU | Estonia | – | registered |
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