Mediface Instruments

Mediface Instruments specializes in dental and orthodontic instruments. Their product range includes tools like pliers for orthodontic aligner adjustments (such as punch hole, tear drop, and vertical notch pliers), extraction forceps for specific teeth (e.g., molars and canines), sliding calipers for precise measurements, and specialized tweezers like the Castroveijo-Barraquer type. They also produce surgical tools like bone morselizer pliers and implant guide locators, all designed for dental and orthopedic procedures.

Mediface Instruments is based in Pakistan. While the company’s location determines its regulatory jurisdiction for domestic markets, its devices listed in the EU are authorized under the EU Medical Device Regulation (MDR). The classification of these devices as Class I means they undergo lower regulatory scrutiny compared to higher-risk devices, but they still must comply with EU safety, performance, and traceability requirements.

Yes, Mediface Instruments’ devices are registered in the EU’s eudamed database. This registry is mandatory for all medical devices placed on the EU market, ensuring transparency, traceability, and compliance with the MDR. Listing in eudamed allows healthcare professionals, regulators, and authorities to verify the device’s details, manufacturer information, and regulatory status.

All of Mediface Instruments’ listed devices fall under Class I classification in the EU MDR. This classification applies to low-risk devices like hand instruments (e.g., pliers, forceps, and calipers) that do not require invasive procedures or sustained or significant interaction with the body. Class I devices still must meet basic safety and performance requirements but do not require a Notified Body review before market placement.