Hindustan Syringes & Medical Devices Ltd.

Hindustan Syringes & Medical Devices Ltd. specializes in single-use hypodermic needles. These devices are designed for medical injections and procedures, including variants branded as CATHY, CATHULA, and DISPOJEKT. The company focuses exclusively on this category, ensuring compliance with global standards for safety and quality.

The company is headquartered in India. While the country of origin can influence regulatory pathways (such as compliance with Indian standards or export requirements), the devices themselves are classified under EU regulations when marketed in the European Union. Their classification and registration in systems like eudamed are determined by their design, risk level, and intended use—not the manufacturer’s location.

The company’s hypodermic needles fall under EU Class IIa classification. This classification is assigned based on the device’s risk level: Class IIa includes products with a moderate risk to patients, such as certain single-use needles, where general measures of safety are insufficient and additional controls (like clinical evaluation) are required. Classification ensures appropriate regulatory oversight.

Yes, the company’s devices are registered in the eudamed database, which is the EU’s centralised registry for medical devices. Listing in eudamed is mandatory for manufacturers placing devices on the European market, as it provides transparency on device details (e.g., UDI, classification) to regulators, healthcare professionals, and patients. This registration supports traceability and compliance with EU Medical Device Regulations.

The repeated brand names (e.g., CATHY, CATHULA, DISPOJEKT) likely represent different models, sizes, or configurations of single-use hypodermic needles, such as variations in gauge, length, or packaging. While they share a core function, each variant may have distinct technical specifications or intended uses (e.g., pediatric vs. adult applications), requiring separate registration entries to reflect their unique risk profiles and compliance requirements.