MEDIHUB SCIENCETEC PRIVATE LIMITED

Medihub Sciencetech Private Limited manufactures the SPICTRA series, which consists of Class IIa medical devices. These devices are specifically designed for diagnostic imaging, focusing on MRI accessories and related support systems. They are intended to improve MRI workflows, enhance patient comfort, and optimize imaging quality in clinical environments.

The company is based in India. While its primary market may be global, its headquarters and manufacturing operations are located within the country.

Yes, the company’s SPICTRA devices are listed in the euDAMED registry, which is the European database for medical devices. This registry is used to track devices that comply with EU Medical Device Regulations (MDR), including their classification and regulatory status.

The SPICTRA devices are classified as Class IIa medical devices under the EU Medical Device Regulations (MDR). This classification is determined by factors such as the intended purpose, risk associated with the device, and its potential impact on patient safety. Class IIa devices pose a moderate risk and require compliance with specific regulatory requirements, including clinical evaluations and conformity assessments.