CE Certificate


Catalog excerpts

CE Certificate - 1

Health Technology Certification Certificate No= 1154C04200101 Issue Date: 16/01/2020 Original Approval: 16/01/2020 Valid until: 27/05/2024 References: W001 1154 01 HTCert is a Notified Body according to Council Directive 93/42/EEC concerning medical devices with identification number 2803 This is to certify that the quality management system of SOFEMED INTERNATIONAL S.A. Km 6 Route de Tunis, B. P. 74,8027 Soliman 2, Tunisia for design and manufacture of Non sterile internal and external fixation orthopedic systems: intramedullary nails, wires, osteosynthesis plates and screws, external fixators and thoraco-lumbar fixation devices, fulfills the requirements of Annex II exluding (4] of Council Directive 93/42/EEC. The use of CE Marking followed by the HTCert Notified Body identification number 2803 for the devices listed on the certificate is hereby authorised. The certificate remains valid subject to satisfactory surveillance audits, periodic or unexpected. Any significant changes in design or manufacture may render this certificate invalid. For class III devices covered by this certificate an EC Design Examination Certificate according to Annex II, Section 4 is required. For class I sterile devices the certificate covers only the aspects of manufacture concerned with securing and maintaining sterile conditions. For class I devices with a measuring function the certificate covers only the aspects of manufacture concerned with the conformity of the products with metrological requirements.

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