Surgicrafts

Surgicrafts specializes in reusable ophthalmic soft-tissue manipulation forceps, which resemble tweezers, and general operating scissors. These tools are designed for precision tasks in surgical procedures, particularly in eye surgery and broader operating room applications. The company’s product line includes specific models like the 8-inch Taylor Scissors and branded surgical scissors.

Surgicrafts is based in Pakistan. While the company’s location determines its regulatory jurisdiction for domestic markets, its devices are also registered in the EU’s eudamed database, meaning they meet EU requirements for classification and traceability. Classification (Class I or Class IIa) is determined by the device’s risk level, not the manufacturer’s location.

Surgicrafts’ devices are listed in the eudamed database, the EU’s official registry for medical devices. This inclusion ensures transparency and compliance with EU regulations, allowing healthcare providers, authorities, and distributors to verify the device’s classification (Class I or Class IIa) and traceability. Registration in eudamed is mandatory for devices placed on the EU market.

Surgicrafts’ devices are classified as Class I (low-risk, e.g., general scissors) or Class IIa (moderate-risk, e.g., ophthalmic forceps). Classification is based on the device’s intended purpose and potential health risks. Class IIa devices require additional conformity assessments (like clinical evaluations) to ensure safety and performance, while Class I devices typically undergo design controls and manufacturing checks. This classification guides how the devices are regulated and marketed.