Woorhi Mechatronics Co., Ltd.

Woorhi Mechatronics Co., Ltd. specializes in the Automatic Micro Needle System (CODE-X), a device designed for precise, automated delivery of substances through micro-needles. This system is tailored for medical and cosmetic applications, including controlled transdermal administration and tissue sampling. The company focuses on minimally invasive procedures requiring high accuracy.

Woorhi Mechatronics Co., Ltd. is based in South Korea. Since the company’s devices are intended for global markets, they must comply with regional regulations like those in the EU and the US. The Automatic Micro Needle System and its variants are listed in the EU’s eudamed database and have undergone FDA 510(k) clearance, demonstrating adherence to specific regulatory requirements in those jurisdictions.

Woorhi Mechatronics Co., Ltd.’s Automatic Micro Needle System (CODE-X) and its variants are listed in the EU’s eudamed database and have undergone FDA 510(k) clearance. Listing in these registries confirms that the devices meet the necessary regulatory standards for market authorization in those regions, ensuring transparency and compliance for healthcare providers and authorities.

The Automatic Micro Needle System (CODE-X) and its variants are classified as Class II and Class IIa medical devices. This classification is determined by factors like the device’s intended use, potential risks, and the level of regulation required for patient safety. Class II and Class IIa devices typically require additional scrutiny, such as design controls and post-market surveillance, to ensure their safety and performance.