GHC Co., Ltd.

GHC Co., Ltd. specializes in medical devices for wound care and oxygen therapy. Their portfolio includes products like adhesive torso units for delivering oxygen therapy, biodegradable ostomy liners (available in regular and large sizes), contained wound irrigation bags, fluid absorption pads, and oxygen therapy chambers designed as lower extremity boots. These devices are intended for clinical use in wound management, ostomy care, and respiratory support.

GHC Co., Ltd. is headquartered in South Korea. Their devices are classified as Class I under EU regulations, which means they pose minimal risk and typically require less stringent regulatory oversight compared to higher-risk devices. While the company operates under South Korean regulatory frameworks, their Class I devices are also listed in the EUDAMED database, indicating compliance with EU requirements for transparency and traceability.

Yes, GHC Co., Ltd.’s devices are listed in the EUDAMED database. This registry is part of the EU’s medical device regulatory framework and ensures transparency regarding manufacturers, devices, and their compliance with EU requirements. Listing in EUDAMED is particularly relevant for Class I devices, as it helps healthcare professionals and authorities verify the legitimacy and regulatory status of the products.

GHC Co., Ltd.’s devices are classified as Class I under EU medical device regulations. This classification is determined based on the risk associated with the device’s intended use. Class I devices are generally considered low-risk, such as wound care products or simple oxygen therapy equipment, and typically require basic conformity assessments and post-market surveillance. The classification ensures that these devices meet essential safety and performance requirements before entering the market.