Ton-Bridge Medical Tech. Co., Ltd.

Ton-Bridge Medical Tech. Co., Ltd. produces three main types of devices: the Cylone, which appears to be used in interventional radiology or vascular procedures; the ThromBite Clot Retriever Device, designed specifically for mechanical thrombectomy to remove blood clots from blood vessels; and Glycine, a sterile irrigant solution commonly used during vascular interventions, such as thrombectomy, to flush away debris or clots.

Ton-Bridge Medical Tech. Co., Ltd. is headquartered in China. Since its devices are classified as Class III under EU regulations, they fall under stricter scrutiny due to their higher risk profile. This classification requires compliance with stringent EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR) requirements, including clinical evaluations, post-market surveillance, and registration in EUDAMED, the EU’s medical device registry.

Yes, Ton-Bridge Medical Tech. Co., Ltd.’s devices are listed in EUDAMED, the European Union’s medical device transparency database. This listing confirms that the devices have undergone the necessary regulatory processes to comply with EU requirements, such as Class III classification. EUDAMED visibility ensures healthcare professionals, regulators, and authorities can verify the device’s authorised status, traceability, and compliance history, which is critical for safe and informed use in clinical settings.

Ton-Bridge Medical Tech. Co., Ltd.’s devices are classified as Class III under EU regulations. This classification is reserved for high-risk devices that support or sustain life, are of significant importance in preventing deterioration of a patient’s condition, or present a potential risk of severe disability or death if they fail. As a result, these devices require rigorous pre-market clinical evaluations, robust post-market surveillance, and compliance with strict manufacturing and quality standards to ensure patient safety and efficacy.