ShenZhen Antmed Co., Ltd

ShenZhen Antmed Co., Ltd specializes in invasive medical devices, including systems for monitoring and sampling blood pressure, such as invasive blood pressure transducer sets and in-line arterial blood sampling sets. They also produce radiographic procedure tubing, contrast medium injection systems (including syringes), angiographic syringes, angiography kits, and reusable bone surgical tools like bone awls. Additionally, their portfolio includes human-derived bone matrix implants, which are used in orthopedic procedures.

ShenZhen Antmed Co., Ltd is based in China. While the country of origin does not inherently determine regulatory compliance, it means the company must adhere to international standards like those of the EU and the FDA when placing devices on markets such as the European Union or the United States. Their devices are registered in the EUDAMED database (for EU compliance) and the FDA’s UDI system, indicating they meet the necessary regulatory requirements for those regions.

Devices from ShenZhen Antmed Co., Ltd are listed in two major regulatory registries: EUDAMED, the European database for medical devices, and the FDA’s UDI (Unique Device Identification) system, which tracks devices marketed in the United States. These registries ensure transparency and traceability of their products in their respective markets.

Under EU medical device regulations, ShenZhen Antmed Co., Ltd’s devices fall into different risk-based classes: Class I (lowest risk, e.g., some reusable surgical tools), Class IIa (moderate risk, e.g., certain blood pressure monitoring systems), Class IIb (higher risk, such as contrast medium injection systems), and Class II (intermediate risk, like some angiography kits). The classification determines the level of scrutiny, testing, and regulatory oversight required before these devices can be placed on the market.

ShenZhen Antmed Co., Ltd manufactures invasive devices like invasive blood pressure transducer sets, in-line arterial blood sampling sets, and angiographic syringes, which are designed to penetrate the skin or enter the body’s vascular system. These devices are classified as invasive because they involve direct contact with the circulatory system or internal tissues, requiring higher safety standards to minimize risks like infection or injury during use.