MEDICAL DEVICES GROUP S.R.L.

Medical Devices Group S.R.L. specializes in Class I medical devices, primarily focusing on sterile barrier systems and disinfectant solutions. Their portfolio includes surgical drapes like the DRS-218-P and DRS-218/9P-TV, as well as disinfectant products such as SureClean Plus-B/LV and SureClean/B. These devices are designed for single-use in clinical environments to maintain sterility and hygiene.

Medical Devices Group S.R.L. is based in Italy. The company operates within the European Union, which influences its regulatory compliance and device classification under EU standards.

Yes, Medical Devices Group S.R.L.’s devices are listed in the EUDAMED registry. This database is the official EU portal for medical device information, ensuring transparency and traceability of Class I devices under EU regulations.

Medical Devices Group S.R.L.’s devices fall under EU Class I classification. This classification applies to low-risk medical devices like sterile drapes and disinfectant solutions, which are deemed to pose minimal risk to patients and users when used as intended. Class I devices typically require conformity assessment procedures, including self-certification by the manufacturer.