Instruments for functional explorations and therapeutic interventionsCardiology and cardiosurgery instrumentsVarious instruments for cardiology and cardiac surgery
Various instruments for cardiology and cardiac surgery -other
EMDN code Z12059099
Manufacturers registered in Europe (EUDAMED) 9
- 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) 15
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 |
|---|---|---|---|
| Datascope Corp. Present in Europe in other categories | United States | Insertion Kit with 6” (15cm) Introducer for use with Sensation 7Fr. 34cc & 40cc Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB Insertion Kit with 6” (15cm) Introducer for use with MEGA 7.5Fr. 30 & 40cc IABs Insertion Kit with 8Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 8Fr Insertion Kit with 7.5Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 7 Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 34cc & 40cc I | K181122 (2018) |
| INSIGHTRA MEDICAL, INC. | United States | Ultra IABP Catheter Kit | K082746 (2009) |
| The Atlanta Dental Supply Company | – | Advance Dental Products | registered |
| Philips Medizin Systeme Böblingen GmbH Present in Europe in other categories | Germany | Spirometry Sensor | registered |
| Airgas Therapeutics, LLC Present in Europe in other categories | United States | – | registered |
| Amphenol Critical Medical Technologies, LLC | United States | – | registered |
| Arrow International, Teleflex | United States | – | K192238 (2019) |
| Arrow Intl., Inc. | United States | – | K250542 (2025) |
| DHL Supply Chain (Netherlands) B.V. | Netherlands | – | registered |
| DOLPHIN LIFE SCIENCE (INDIA) LLP | India | – | registered |
| EverX / Bindra | Australia | – | registered |
| Life Science Outsourcing, Inc. | United States | – | registered |
| Maquet Critical Care AB Present in Europe in other categories | United States | – | registered |
| Philips Medical Systems Nederland B.V. Present in Europe in other categories | Netherlands | – | registered |
| Tokai Medical Products,Inc. | Japan | – | registered |
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