ISO 10993 - 1: 2018
Biological Evaluation of Medical Devices
This is to certify that:
Medtronic Xomed, Inc
6743 Southpoint Drive North,
Jacksonville FL 32216
USA
Hold Certificate No:
89653200
Isocerts assessed and approved that the firm meets the requirements for the designated standard.
Scope
Ventilation Tubes and Related Surgical
Equipment; Middle Ear Prostheses; Disposable Sterile Surgical Instruments/Devices and
Non-Sterile Surgical Instruments (With Suction);
Surgical Drill Systems; Sinus Endoscopy Systems;
Nerve Integrity Monitoring Systems; Nerve Simulators; Rhinology, Laryngeal, and Facial Implants; Endotracheal Tube Systems; Disposable Surgical Invasive Sponge Dressings, Packing and Wipes; Bone Conduction Hearing System;
including Fitting Software and magnetic Implants
Manager Of System Certification
Initial Issue Date: 24-10-2021
Validity of this certificate: 23-10-2024
