Shahab Surgical Industries

Shahab Surgical Industries produces a range of dental and surgical instruments. Their portfolio includes kidney trays for medical procedures, orthodontic pliers, non-surgical retractors, and forceps. They also manufacture dental-specific tools like amalgam guns, cord packers, dental explorers, and examination kits. Additionally, they offer mixing tools such as cement and mixing spatulas, articulator devices for dental use, and instrument stands for clinical settings.

Shahab Surgical Industries is based in Pakistan. While the company’s devices are registered in the EUDAMED database—indicating compliance with European regulatory requirements—their primary regulatory focus appears tied to EU markets. The manufacturer’s location does not inherently determine device classification, but in this case, their products fall under Class I under EU regulations, which is the lowest risk category for medical devices.

Yes, Shahab Surgical Industries’ devices are listed in EUDAMED, the European Union’s medical device registry. This matters because EUDAMED provides transparency on device manufacturers, their products, and regulatory status within the EU. Listing in this database helps healthcare professionals, regulators, and authorities verify compliance with EU medical device regulations, ensuring traceability and accountability for Class I devices.

Shahab Surgical Industries’ devices are classified as Class I under EU regulations. This classification applies to low-risk medical devices, such as many dental and surgical instruments, which pose minimal risk to patients. Class I devices typically require basic compliance measures, such as manufacturer declarations of conformity, but do not always need third-party involvement unless they fall under specific exemptions or are reusable surgical instruments.