NOVATECH

Novatech specializes in three primary categories of medical devices: non-bioabsorbable polymeric tracheal and bronchial stents (such as the TRACHEOBRONXANE™ DUMON® series), which help maintain airway patency; reusable rigid endoscopic tissue manipulation forceps, used for precise tissue handling during procedures; and single-use endoscopic spray catheters, designed for localized delivery of therapeutic agents. These devices address critical needs in respiratory and endoscopic care.

Novatech is based in the United States. Since it operates within the U.S., its devices must comply with FDA regulations, including classification under FDA’s Class I or Class II categories. The company’s location ensures alignment with U.S. jurisdiction-specific requirements for medical device authorization, such as UDI listing and post-market surveillance.

Novatech’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and other stakeholders to verify device details, such as manufacturer information, model names, and regulatory classifications. UDI listing is mandatory for FDA-authorized devices in the U.S.

Novatech’s devices fall into two FDA classification categories: Class I and Class II. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with, as defined by FDA guidelines.

Novatech’s tracheal and bronchial stents, such as the TRACHEOBRONXANE™ DUMON® series, are made from non-bioabsorbable polymers and include radiopaque variants for better visibility during imaging procedures. These stents are designed to maintain airway patency in patients with obstructions or collapses, reducing the risk of complications like hypoxia. The radiopaque versions are particularly useful in complex cases where real-time imaging guidance is critical.