Full Quality Assurance System Directive 93/42/EEC on Medical devices, Annex II excluding (4)

Transcription

1 EC CERTIFICTE s UJ Number: CE02 Full uality ssurance System Directive 9342EEC on Medical devices, nnex II excluding (4) (Devices in Class lla, lib or III) Manufacturer: Institut Straumann G 7, 'L (i Regenerative materials containing nimal Tissues: ''.[llll, Material for Periodontal Regeneration and intra-oral woundhealing DEKR grants the right to use the EC Notified Body Identification Number illustrated below to accompany; the CE Marking of Conformity on the products concerned conforming to the required Technical inji Documentation and meeting the provisions of the EC-Directive which apply to them:,,;;,' DEKR hereby declares that the above mentioned manufacturer fulfils the relevant provisions of 'Besluit Medische Hulpmiddelen', the Dutch transposition of the Council Directive 9342EEC of June 14, 1993 concerning Medical design, manufacture and final inspection for the above mentioned product category in accordance to the provisions of nnex II of Council Directive 9342EEC of June 14, 1993 and is subject to periodical surveillance. For placing on the market of Class III devices an additional EC design examination certificate according to nnex II (4) is mandatory. This certificate is valid until: 1 December 2023 Issued for the first time: 17 March 2016 Reissued: 6 December 2018 DEKR Certification B.V. ^^ B.T.M. Holtus J.. van Vugt DEKR Certification B.V. is Notified Body with ID no DEKR Certification B.V. Meander 1051, 6825 MJ rnhem P.O. Box 5185, 6802 ED rnhem, The Netherlands T F (flmw.dekra-certification.com Company registration

2 EC CERTIFICTE 81 s ^ UJ Number: CE04 Full uality ssurance System Directive 9342EEC on Medical devices, nnex II excluding (4) (Devices in Class lla, lib or III) Manufacturer: Institut Straumann G Synthetic regenerative materials: - Bone substitutes, Resorbable, Osteoconductive Bone Filler - Dental material for removal of the smear layer DEKR grants the right to use the EC Notified Body Identification Numberillustrated below to accompany;",' the CE Marking of Conformity on the products concerned conforming to the required Technical Documentation and meeting the provisions of the EC-Directive which applyto.t^^m: DEKR hereby declares that the above mentioned manufacturer fulfils the relevant provisions of 'Besluit Medische Hulpmiddelen', the Dutch transposition of the Council Directive 9342EEC of June 14, 1993 concerning Medical design, manufacture and final inspection for the above mentioned product category in accordance to the provisions of nnex II of Council Directive 9342EEC of June 14, 1993 and is subject to periodical surveillance. For placing on the market of Class III devices an additional EC design examination certificate according to nnex II (4) is mandatory. i\ This certificate is valid until: 1 December 2023 Issued for the first time: 17 March 2016 Reissued: 6 December 2018 DEKR Certification B.V. B.T.M. Holtus ^^ J.. van Vugt DEKR Certification B.V. is Notified Body with ID no DEKR Certification B.V. Meander 1051, 6825 MJ rnhem P.O. Box 5185, 6802 ED rnhem, The Netherlands

3 a EC CERTIFICTE < c^ ^ UJ Number: CE05 Full uality ssurance System Directive 9342EEC on Medical devices, nnex II excluding (4) (Devices in Class lla, lib or III) JUIiS. Manufacturer: ^SIBi Institut Straumann G ^iiif!li, ^"I%liJ%%^ ' ';':111. Non active implantable bone substitute material, bovine origin DEKR grants the right to use the EC Notified Body Identification Number illustrated below to accompany, the CE Marking of Conformity on the products concerned conforming to the required Technical f,'; Documentation and meeting the provisions of the EC-Directive which apply to them: ddendum, initially dated 15 November 2016 DEKR hereby declares that the above mentioned manufacturer fulfils the relevant provisions of 'Besluit Medische Hulpmiddelen', the Dutch transposition of the Council Directive 9342EEC of June 14, 1993 concerning Medical design, manufacture and final inspection for design, manufacture and final inspection for the above mentioned product category in accordance to the provisions of nnex II of Council Directive 9342EEC of June 14, 1993 and is subject to periodical surveillance. dditionally, DEKR hereby declares that the manufacturer fulfils the relevant provisions as specified in nnex I of Commission Regulation of 8 ugust, 2012 concerning medical devices manufactured utilising tissue of animal origin. For placing on the market of Class III devices an additional EC design examination certificate according to nnex II (4) is mandatory. This certificate is valid until: 20 January 2020 Issued for the first time: 15 November 2016 Reissued: 25 May 2018 DEKR Certification B.V. l!i: ':!! ing...m. Laan DEKR Certification B.V. is Notified Body with ID no DEKR Certification B.V. Meander 1051, 6825 MJ rnhem P.O. Box 5185, 6802 ED rnhem, The Netherlands

4 B;" - K. 'fill^i^sifii ^; :&!s^^s ^LU DDENDUM Belonging to certificate: CE05 CE MRKING OF CONFORMITY MEDICL DEVICES 11!ffi^^FiW Non active implantable bone substitute material, bovine origin Issued to: Institut Straumann G % z This certificate covers the following productfs^ rsy - Straumann XenoOss - Straumann Cerabone. Initial date: 15 November 2016 Revision date: 2 December 2016 'If, :!^Vi!Hi. DEKR Certification B.V. ing...m. Laan DEKR Certification B.V. is Notified Body with ID no DEKR Certification B.V. Meander 1051, 6825 MJ rnhem P.O. Box 5185, 6802 ED rnhem, The Netherlands

5 M.. ''. EC CERTIFICTE s^lu Number: CE06 Full uality ssurance System Directive 9342EEC on Medical devices, nnex II excluding (4) (Devices in Class lla, lib or III) Manufacturer: Institut Straumann G f bsorbable collagen membrane, porcine origin DEKR grants the right to use the EC Notified Body Identification Number illustrated below to accompany, the CE Marking of Conformity on the products concerned conforming to the required Technical Documentation and meeting the provisions of the EC-Directive which apply to them: ddendum, initially dated 15 November 2016 DEKR hereby declares that the above mentioned manufacturer fulfils the relevant provisions of 'Besluit Medische Hulpmiddelen', the Dutch transposition of the Council Directive 9342EEC of June 14, 1993 concerning Medical design, manufacture and final inspection for design, manufacture and final inspection for the above mentioned product category in accordance to the provisions of nnex II of Council Directive 9342EEC of June 14, 1993 and is subject to periodical surveillance. dditionally, DEKR hereby declares that the manufacturer fulfils the relevant provisions as specified in nnex I of Commission Regulation of 8 ugust, 2012 concerning medical devices manufactured utilising tissue of animal origin. For placing on the market of Class III devices an additional EC design examination certificate according to nnex II (4) is mandatory. This certificate is valid until: 18 June 2019 Issued for the first time: 15 November 2016 Revised: 25 January 2017 DEKR Certification B.V.,.c~> ing...m. Laan DEKR Certification B.V. is Notified Body with ID no DEKR Certification B.V. Meander 1051, 6825 MJ rnhem P.O. Box 5185, 6802 ED rnhem, The Netherlands

6 t DDENDUM s m s^uj Belonging to certificate: CE06 CE MRKING OF CONFORMITY MEDICL DEVICES 11 bsorbable collagen membrane, porcine origin Issued to: Institut Straumann G This certificate covers the following - Straumann GBR Membrane - Straumann Jason Membrane ' Initial date: 15 November 2016 Revision date: 2 December 2016 DEKR Certification B.V. if 7 z % It wiii ^wrflmh. :<-<;^%r;4wl i"''7.'::7^^f c~> ing...m. Laan DEKR Certification B.V. is Notified Body with ID no DEKR Certification B.V. Meander 1051, 6825 MJ rnhem P.O. Box 5185, 6802 ED rnhem, The Netherlands T F Company registration