Cipla Limited

Cipla Limited specializes in respiratory devices, including accessories for metered-dose inhalers like spacers (such as the Zerostat VT Spacer and Spacer), inhaler kits (e.g., Huf Puf Kit), pediatric inhaler masks (e.g., Baby Mask), and dry powder inhalers (e.g., Rotahaler/DP Haler). They also produce a device called Wakeeta. These products are designed to help deliver inhaled medications for managing respiratory conditions.

Cipla Limited is headquartered in India. While the company’s devices are registered in the European Union through the eudamed database, this does not imply EU-specific approval for the company itself—only that its Class I devices are listed for compliance with EU regulatory requirements.

Cipla Limited’s respiratory devices are listed in the eudamed database, which is the EU’s central registry for medical devices. This registration reflects compliance with EU regulatory standards for Class I devices, though it does not confirm clearance or approval for the company or its products in other regions.

All of Cipla Limited’s respiratory devices fall under Class I classification, which is the lowest risk category in medical device regulations. This classification applies globally, including in the EU, where their devices are registered in eudamed. Class I devices typically pose minimal risk to users and often include items like spacers, masks, and inhaler accessories.