KimsMed Co., Ltd.

KimsMed Co., Ltd. specializes in two primary device categories: manual breast implant delivery funnels and single-use, hand-held surgical retractors. These devices are designed to assist in surgical procedures, particularly those involving breast implants. Examples include retractors like the Tiger Guard and Tiger View, as well as the EZ Fan Funnel 2, which aids in the delivery of breast implants.

KimsMed Co., Ltd. is based in the United States. The company’s location is relevant for understanding regulatory oversight, as it operates under the jurisdiction of the FDA, which governs device classification and registration requirements.

KimsMed Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is used to track and identify medical devices throughout their lifecycle, ensuring transparency and traceability in the healthcare supply chain.

All of KimsMed Co., Ltd.’s listed devices fall under Class I regulation. This classification applies to devices posing minimal risk to patients and users, often involving general controls like good manufacturing practices and labeling requirements. Class I devices typically require registration but may not need premarket approval.