Certificate of Registration
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1 Certificate of Registration QUALITY MANAGEMENT SYSTEM - ISO 13485:2003 & EN ISO 13485:2012 This is to certify that: Sanatmetal Orthopaedic & Traumatologic Equipment Manufacturer Ltd. Faiskola u Eger Holds Certificate Number: MD and operates a Quality Management System which complies with the requirements of ISO 13485:2003 & EN ISO 13485:2012 for the following scope: Design, manufacture and distribution of sterile and non-sterile traumatologic, orthopaedic and dental implants, including associated instrumentation. For and on behalf of BSI: Gary Fenton, Global Assurance Director Originally registered: 24/06/2004 Latest Issue: 12/06/2013 Expiry Date: 23/06/2016 Page: 1 of 1 This certificate was issued electronically and remains the property of BSI and is bound by the conditions of contract. An electronic certificate can be authenticated online. Printed copies can be validated at Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: BSI Assurance UK Limited, registered in England under number at 389 Chiswick High Road, London W4 4AL, UK. A Member of the BSI Group of Companies.
2 Certificate of Registration QUALITY MANAGEMENT SYSTEM - ISO 9001:2008 This is to certify that: Sanatmetal Orthopaedic & Traumatologic Equipment Manufacturer Ltd. Faiskola u Eger Holds Certificate No: FM and operates a Quality Management System which complies with the requirements of ISO 9001:2008 for the following scope: The design and manufacture of both sterile and non sterile implants for orthopaedic and trauma, including associated instrumentation. For and on behalf of BSI: Gary Fenton, Global Assurance Director Originally registered: 02/12/1997 Latest Issue: 12/04/2013 Expiry Date: 15/04/2016 Page: 1 of 1 This certificate was issued electronically and remains the property of BSI and is bound by the conditions of contract. An electronic certificate can be authenticated online. Printed copies can be validated at or telephone +49 (0)6181/ Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: BSI Assurance UK Limited, registered in England under number at 389 Chiswick High Road, London W4 4AL, UK. A Member of the BSI Group of Companies.
3 Certificate of Registration ENVIRONMENTAL MANAGEMENT SYSTEM - ISO 14001:2004 This is to certify that: Sanatmetal Orthopaedic & Traumatologic Equipment Manufacturer Ltd. Faiskola u Eger Holds Certificate No: EMS and operates an Environmental Management System which complies with the requirements of ISO 14001:2004 for the following scope: The design and manufacture of both sterile and non sterile implants for orthopaedic and trauma, including associated instrumentation. For and on behalf of BSI: Gary Fenton, Global Assurance Director Originally registered: 11/08/2005 Latest Issue: 25/04/2014 Expiry Date: 19/04/2017 Page: 1 of 1 This certificate was issued electronically and remains the property of BSI and is bound by the conditions of contract. An electronic certificate can be authenticated online. Printed copies can be validated at or telephone +49 (0) Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: BSI Assurance UK Limited, registered in England under number at 389 Chiswick High Road, London W4 4AL, UK. A Member of the BSI Group of Companies.
4 EC Certificate - Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4 No. CE Issued To: Sanatmetal Orthopaedic & Traumatologic Equipment Manufacturer Ltd Eger Faiskola u.5 H-3300 In respect of: For the design, development and manufacture of sterile and non-sterile trauma implants, dental screws and spinal implants, and associated instruments. on the basis of our examination of the quality assurance system under the requirements of Council Directive 93/42/EEC, Annex II excluding section 4. The quality assurance system meets the requirements of the directive. For the placing on the market of class III products an Annex II section 4 certificate is required. For and on behalf of BSI, a Notified Body for the above Directive (Notified Body Number 0086): Gary Fenton, Global Assurance Director First Issued: 10 December 1997 Date: 10 September 2014 Expiry Date: 12 September 2019 Page 1 of 1 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company named on this certificate, unless specifically agreed with BSI. This certificate was issued electronically and is bound by the conditions of the contract. Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: BSI Assurance UK Limited, registered in England under number at 389 Chiswick High Road, London W4 4AL, UK. A member of BSI Group of Companies.
5 EC Certificate - Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4 List of Significant Subcontractors Recognised as being involved in services relating to the product covered by: Certificate No: CE Date: 10 September 2014 Issued To: Sanatmetal Orthopaedic & Traumatologic Equipment Manufacturer Ltd Eger Faiskola u.5 H-3300 Subcontractor: Dispomedicor Zrt. Furedi ut 98 H-4032, Debrecen Service(s) supplied Gamma Sterilization Page 1 of 1 Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: BSI Assurance UK Limited, registered in England under number at 389 Chiswick High Road, London W4 4AL, UK. A member of BSI Group of Companies.
6 EC Certificate - Full Quality Assurance System Certificate History Certificate No: CE Date: 10 September 2014 Issued To: Date Sanatmetal Orthopaedic & Traumatologic Equipment Manufacturer Ltd Eger Faiskola u.5 H-3300 Reference Number Action 10 December First Issue 13 September Change of Company name from DePuy Sanatmetal to Sanatmetal Orthopaedic and Traumatalogic Equipment Manufacturer Ltd 01 August Year review and change of scope to include sterile hip prostheses and the addition of Dispomedicor RT ( as a subcontractor 28 September Certificate renewal, modification to certificate scope removal of design, development and manufacture of sterile hip prostheses sterile hip prostheses and correction to company name from Traumatalogic to Traumatologic. Further modification to certificate scope to, For the design, development and manufacture of sterile and non-sterile trauma implants, dental screws and thoraco-lumbar transpedicular spinal implants, and associated instruments. Change of subcontractor activity from sterilization to Gamma Sterilization and Subcontractor name change, from Dispomedicor Rt to Dispomedicor Zrt. 10 September Certificate Renewal Change to scope from thoraco-lumbar transpedicular spinal implants to spinal implants Page 1 of 1 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company named on this certificate, unless specifically agreed with BSI. This certificate was issued electronically and is bound by the conditions of the contract. Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: BSI Assurance UK Limited, registered in England under number at 389 Chiswick High Road, London W4 4AL, UK. A member of BSI Group of Companies.
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