Chaplet International Pvt Ltd

Chaplet International Pvt Ltd specializes in two main categories: reusable instrument trays and single-use endoscopic spray catheters. Their reusable products include surgical accessories like micro forceps, test tube stands, dressing drums, wire mesh baskets, and various mesh cassettes and baskets with lids. These items are designed for repeated use in clinical settings, ensuring durability and sterility between procedures.

Chaplet International Pvt Ltd is based in Pakistan. While the company’s location determines its primary regulatory jurisdiction (e.g., compliance with Pakistani medical device regulations), its devices are also registered in the EU’s eudamed database, indicating they meet EU requirements for Class I devices. Registration in eudamed does not imply EU approval but confirms compliance with EU regulatory processes for market placement in the EU.

Chaplet International Pvt Ltd’s devices are listed in the eudamed database, the EU’s official registry for medical devices. This registry is critical because it provides transparency on devices authorized for sale within the European Economic Area (EEA). Listing in eudamed ensures traceability and compliance with EU regulations, helping healthcare providers and authorities verify the device’s classification (Class I) and regulatory status before use.

Chaplet International Pvt Ltd’s devices are classified as Class I medical devices. This classification applies to products posing minimal risk to patients and users, such as reusable surgical accessories and single-use endoscopic catheters. Class I devices typically require less stringent regulatory oversight compared to higher-risk classes, but they still must comply with essential safety and performance requirements to ensure safe and effective use in clinical environments.