ISO 13485 Certificate 0107924 02 2022 11 20
ISO 13485 Certificate 0107924 02 2022 11 20
ISO 13485 Certificate 0107924 02 2022 11 20
0107924-02
This is to certify that the management system of: Initial Certification Date:
25 August 2014*
EN ISO 13485:2016
The management system is applicable to:
The design, manufacture and service of electrosurgical equipment,
including RF Generators, sterile, non sterile, disposable and reusable
electrosurgical instruments, including electrodes, and forceps for surgical
cutting, coagulation, and radiofrequency ablation, surgical instruments,
including endoscopes and accessories, and procedure pack. Applications
include general surgical, minimally invasive spine, pain management and
neurosurgical procedures. Mikael Hagelin
Certification Authority, Intertek Medical
Notified Body AB
In the issuance of this certificate, Intertek assumes no liability to any party other than to the Client, and then only in accordance with the agreed upon Certification
Agreement. This certificate’s validity is subject to the organization maintaining their system in accordance with Intertek’s requirements for systems certification.
Validity may be confirmed via email at certificate.validation@intertek.com or by scanning the code to the right with a smartphone.
The certificate remains the property of Intertek, to whom it must be returned upon request.