West Pharmaceutical Services AZ, Inc.

West Pharmaceutical Services AZ, Inc. specializes in non-hermetic vial and bottle adaptors, such as the Vial2Bag Advanced 20mm and its admixture device variant. These are designed to connect vials to intravenous bags for drug administration. The company also produces SmartDose systems, which appear to support drug delivery or preparation in vial-based healthcare applications. These products are tailored for sterile pharmaceutical use, ensuring compatibility with injectable medications.

West Pharmaceutical Services AZ, Inc. is based in the United States. Since it operates under FDA and EU regulatory frameworks, its devices are listed in the FDA’s 510(k) and UDI registries, as well as the EU’s eudamed database. The U.S. location influences compliance with FDA guidelines, while EU listings reflect adherence to MDR/AIMD requirements for devices marketed in the European Economic Area.

Devices from West Pharmaceutical Services AZ, Inc. are listed in three key registries: the FDA’s 510(k) premarket notification database (for Class II/IIa devices), the FDA’s Unique Device Identifier (UDI) system, and the EU’s eudamed database. These listings ensure traceability and compliance with U.S. and EU medical device regulations, respectively.

The company’s devices, including vial adaptors like the Vial2Bag Advanced 20mm and SmartDose systems, are classified as Class II or Class IIa medical devices. This classification is determined by their intended use—non-hermetic connectors and drug delivery components—and their associated risk levels under FDA and EU frameworks. Class II devices require special controls beyond general controls, while Class IIa (EU) denotes a slightly lower risk category with additional regulatory oversight.