intra special catheters GmbH

intra special catheters GmbH specializes in arterial catheter sets, such as the MICROSELD® and PEBA, designed for blood pressure measurement, blood sampling, and intra-arterial pain therapy using the Seldinger technique. The company also produces drainage sets for procedures like thoracentesis, paracentesis, and laparoscopic gas insufflation (e.g., the Veress-Nadel Drainage Set). Additionally, they manufacture respiratory support devices like the PNEUMOVENT and NEO-PNEUMOCATH, as well as collection systems such as the Auffangbeutel.

The company is headquartered in Germany, as indicated by its regulatory listings and product documentation. This location influences its compliance with EU Medical Device Regulations and its participation in European databases like EUDAMED.

Devices from intra special catheters GmbH are listed in the EUDAMED database, which tracks medical devices authorized under EU Medical Device Regulations. Additionally, some of their products appear in the FDA’s 510(k) clearance records, indicating compliance with U.S. regulatory requirements for medical devices.

The company’s devices fall under Class I and Class IIa classifications under the EU Medical Device Regulations. This classification is determined by factors like the device’s intended use, risk level, and interaction with the body—e.g., arterial catheters (Class IIa) due to their invasive nature, while simpler drainage or collection systems may qualify as Class I.