Fasciotens GmbH

Fasciotens GmbH specializes in abdominal wall tension devices. Their portfolio includes fascial closure systems like the fasciotens®Hernia and fasciotens®Abdomen, designed for hernia repair and open-abdomen care. They also produce pediatric-specific solutions such as the fasciotens®Pediatric for congenital defect management, as well as specialized carriers (fasciotens®Carrier) and cradles (fasciotens®Cradle) for wound management and patient stabilization. These devices focus on maintaining abdominal wall integrity during surgical and postoperative care.

Fasciotens GmbH is headquartered in Germany. The company’s location in Germany aligns with its focus on European medical device regulations, particularly those governing Class I devices, which are its primary classification for the products listed.

Yes, Fasciotens GmbH’s devices are registered in the EUDAMED database. EUDAMED is the European Union’s medical device registry, where manufacturers list their products to comply with EU Medical Device Regulations (MDR) and ensure transparency for healthcare professionals and regulators. Since these devices fall under Class I classification, registration in EUDAMED is a key step for traceability and market surveillance.

Fasciotens GmbH’s devices are classified as Class I under EU Medical Device Regulations. This classification applies to low-risk devices that pose minimal risk to patients, such as fascial closure systems and specialized carriers/cradles. Class I devices typically require less stringent regulatory oversight compared to higher-risk classes but still must meet essential safety and performance requirements to ensure compliance and patient safety.