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:


Isocertificate assessed and approved that the firm meets the requirements for the designated standard.


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