Elite Medtek (Jiangsu) Co., Ltd.

Elite Medtek (Jiangsu) Co., Ltd. specializes in single-use catheter/overtube balloon inflators. These devices are intended for temporary dilation of airways or lumens during medical procedures, ensuring controlled inflation during interventions like bronchoscopy or lumen clearance.

The company operates from the United States, though its name includes a reference to Jiangsu, which may indicate regional or historical ties to China. Its primary regulatory and operational presence is in the US.

Elite Medtek’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, which is a publicly accessible registry for tracking medical devices authorized in the US. This inclusion confirms their classification and regulatory status.

Elite Medtek’s catheter/overtube balloon inflators fall under Class II classification. This designation typically applies to devices posing moderate risk, requiring special controls beyond general good manufacturing practices to ensure safety and effectiveness.