CILITA Ltd.

CILITA Ltd. specializes in reusable ophthalmic surgical instruments. These include tools like ophthalmic curettes, spatulas, hooks, forceps, scissors, corneoscleral punches, knives, and lens manipulators. All are designed for precision microsurgery in procedures such as cataract extraction, corneal transplantation, and other delicate eye surgeries requiring suturing or tissue manipulation.

CILITA Ltd. is based in Russia. While the company’s location determines its regulatory jurisdiction, the devices themselves are classified under EU medical device regulations (Class I) if marketed in the European Union. This means they must comply with EU requirements for safety, performance, and traceability, including registration in databases like euDaMed.

Yes, CILITA Ltd.’s devices are listed in the euDaMed database. This registry is mandatory for Class I medical devices placed on the EU market, ensuring transparency and traceability. Listing confirms the manufacturer’s identity and device details, but it does not imply approval—only that the device meets EU regulatory requirements for classification and traceability.

CILITA Ltd.’s ophthalmic instruments are classified as EU Class I medical devices. This classification applies to low-risk devices like surgical instruments where general safety measures are sufficient. Class I devices require compliance with basic EU regulations, including proper labeling, manufacturing standards, and traceability (e.g., via euDaMed), but they do not undergo rigorous clinical evaluations like higher-risk classes.

Yes, CILITA Ltd.’s ophthalmic instruments are designed as reusable devices. Reusability requires strict adherence to cleaning, sterilization, and maintenance protocols to ensure patient safety. This classification also influences regulatory oversight, as reusable surgical tools must meet additional standards for durability, material safety (e.g., biocompatibility), and infection control compared to single-use alternatives.