MAQUET GETINGE GROUP Certificate of Compliance Product group: Ref No - 3175401242 LC NUMBER: 036IMFN163010002 CONTRACT NUMBER: BERLIN/N/QM/CU/MAQUETI/G13CARD/MOH/2016/297 Product. Product Number | Amount | Lot Number Expiry Date VKMO 78000 701064525 95 92212477 Sep 2018 ‘VKMO 78000 701064525 332 92212476 Sep 2018 VKMO 78000 701064525 336 92212475 Sep 2018 VKMO 78000 701064525 336 92212474 ‘Sep 2018 VKMO 78000 701064525 50 92212194 Sep 2018 VKMO 78000 701064525 336 92212195 Sep 2018 VKMQ 78000 701064525 118 92212194 Sep 2018 VKMO 78000 701064525 336 92212193 ‘Sep 2018 VKMO 78000 701064525 336 92207594 Sep 2018 VKMO 78000 701064525 5 92207225 ‘Jul 2018 H 417600 701071692 228 92210386 ‘Aug 2018 H447600 701071692 228 92210385 Aug 2018 H 417600 701071692 228 92210384 ‘Aug 2018 H 417600 701071692 228 92210383 ‘Aug 2018 H 117600 701071692 228 92210382 Aug 2018 H 417600 701071692 12 92210282 ‘Aug 2018 H 417600 701071692 1 92213436 Oct 2018. 417600 701071692 216 92210282 ‘Aug 2018 H117600 701071692 228 92210281 ‘Aug 2018 H117600 701071692 228 92210280 Aug 2018 117600 701071692 228 92210279 ‘Aug 2018 H 117600 701071692 227 92207598 ‘Aug 2018 VKMO 30000 701050114 95 92206795 Sep 2018 VKMO 30000 701050111 18 92206800 Aug 2048 VKMO 30000 701050111 1 92206797 Sep 2018 VKMO 10000 701050109 23 92209809 ‘Aug 2018 P -0400 701005142 270 92209881 ‘Aug 2018 P= 0410 701005143 60 ‘92209883 ‘Aug 2018 P - 0420 701005144 10 92209884 ‘Aug 2018 H 117602 701071695 114 92207600 Jul 2018 H 417603 701071696 23 92207601 Jul 2018 HBF 140 701004263 248 70113922 ‘Aug 2018 HBF 140 701004263 8 70114254 Sep 2018 B.0035n Version 2 2015-0908MAQUET GETINGE GROUP Test ‘Specification ‘Method Results Raw Material | incoming inspection performed | Meets MCP ‘According to specification Inspection ‘at MCP per company internal procedures ‘Specification Bioburden Bioburden monitoring routinely | Product Meets | According to specification performed on pre-steriiized | MCP internal product and at several points in | Specification the production process. Testing is conducted in accordance with 180 11737~1 Biocompatiblity | The above listed devices are | As defined in ‘According to specification ‘CE-marked and comply to EN | relevant ISO. ISO 10993-1 Standers Pyrogenicity(LAL) | < 20 EU per product USP, Ph. Eur. | According to specification Sterility EO Sterilization per ISO 11135- | Minimum sterility | According to specification 1 assurance level (SAL) of 10° MAQUET Cardiopulmonary GmbH hereby certifies that the medical devices listed above, Identified by REF no. and LOT no., have been manufactured and tested in compliance with the appropriate and internationally recognized good practices in the manufacture and quality control ISO 9001, ISO 13485 and Annex II of European Medical Device Directive 93/42/EEC. Date: _ 2016-12-14 Jochen Kunz ~ ‘Quality Assurance - MAQUET Cardiopulmonary GmbH Kehler StraBe 34 D-76437 RastattiGermany MAQUET GETINGE GRoup Ketter sig omer Gr TAS Fah, Gomy FB.0033n Version 02 2016-08-08