TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Teva Pharmaceutical Industries Limited specializes in intravenous administration accessories. Their devices include medication transfer sets like the TEVADAPTOR® Connecting Set, spike port adaptors (e.g., TEVADAPTOR® Spike Port Adaptor), syringe adaptors, and vial adaptors (e.g., TEVADAPTOR® 28mm Vial Adaptor). These products are designed for safe medication transfer and infusion in hospital or clinical settings, often featuring components like injection sites or luer lock connectors for compatibility with IV lines and drug vials.

Teva Pharmaceutical Industries Limited is based in the United States, where its devices are developed and manufactured. Since these devices fall under U.S. regulatory oversight, they must comply with FDA requirements for medical devices. The company’s U.S. location ensures adherence to local regulations, including classification, labeling, and reporting standards for infusion-related accessories.

Teva Pharmaceutical Industries Limited’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry includes details like device identifiers, manufacturers, and classifications, ensuring traceability and compliance tracking for Class II medical devices like their intravenous administration accessories.

Teva Pharmaceutical Industries Limited’s devices are classified as Class II under the FDA’s medical device classification system. This classification applies to devices that generally pose moderate risk and require special controls (e.g., performance standards, labeling requirements) to ensure safety and effectiveness. Examples include their TEVADAPTOR® products, which are designed for medication transfer and infusion in clinical settings.