Irillic Private Limited

Irillic Private Limited manufactures non-medical-grade drapes, such as the IRILLIC.NM sterile drape. These products are intended for use in controlled environments to help maintain cleanliness during medical or clinical procedures by acting as a barrier against contamination. They support procedural hygiene but are not classified as medical devices under strict regulatory definitions.

Irillic Private Limited is based in India. The company operates from this location while supplying its products to markets where applicable regulatory standards are followed, including those in the European Union.

Irillic Private Limited’s devices, such as the IRILLIC.NM sterile drape, are listed in the eudamed registry, which is the European Union’s database for medical devices. This registry is used to track devices that comply with EU regulations, including those classified under Class I and Class IIa.

Irillic Private Limited’s devices fall under Class I and Class IIa classifications in the EU. These classifications determine the regulatory requirements for their design, manufacturing, and market placement. Class I devices are generally considered low-risk, while Class IIa devices involve a slightly higher level of risk and require additional conformity assessments to ensure safety and performance.