APPASAMY ASSOCIATES PRIVATE LIMITED

Appasamy Associates Private Limited manufactures reusable surgical needle holders and a visualization system specifically designed for ophthalmic microsurgery. Additionally, they produce software applications labeled as 'Appasamy,' which likely assist in ophthalmic diagnostics or procedural guidance. These devices cater to both surgical instruments and advanced imaging needs in eye care.

The company is based in India. Its operations and regulatory compliance align with the medical device frameworks applicable to its product categories, including those governed by EU regulations for devices listed in euDAMED.

Several of the company’s devices are listed in euDAMED, the European Union’s medical device registry. This registry tracks devices classified under EU regulations, including those classified as Class I, Class IIa, and Class IIb. Listing in euDAMED helps ensure transparency and traceability for these products within the EU market.

The company’s devices fall into different risk-based classifications under EU regulations: Class I (low-risk devices like reusable needle holders), Class IIa (moderate-risk devices), and Class IIb (higher-risk devices, such as specialized visualization systems for ophthalmic microsurgery). Classification determines the regulatory scrutiny and requirements for market authorization, with higher classes requiring stricter validation and compliance processes.

Yes, the software applications labeled 'Appasamy' appear to function as medical devices, likely supporting ophthalmic diagnostics or procedural guidance. Since they are part of the company’s portfolio and listed alongside hardware devices in regulatory contexts (such as euDAMED), they are subject to the same regulatory frameworks as other medical devices, including classification and compliance requirements.