Flex Certificate of Conformance for Zeiss Flextronics Manufacturing (Singapore) Pte. 1 Kallang Place ingapore 339211 Main: +65 6507 6507 wow flextronics.com Product Name HFA3 MODEL, 840 | Product Part Number 2660021170745 Instrument Serial Number | 840-17. Product Revision A | Quantity 1 | This is to certify that the product listed above has been manufactured by FLEX in accordance to and fully complies with all of the specifications and requirements associated with the assembly and sysicm requirements. Name: Nor MEK Ge Het Signature QD ___ Date: _ Quality Representative ty 9Gc18 Page t of 1 COMPANY CONFIDENTIAL This Bocument is contrlied in DMS. All Copies (olectiorc oF printed) are considered uncontrolled.Certificate of Conformity Name of commodity: Quantity to be supplied: Article Number: Serial Number: Manufacture/Inspection Date. HFA3 MODEL 840 1 2660021170745 840-17287 1 December 2018 Carl Zeiss Meditec, Inc 5160 Hacienda Drive Dublin, CA 94568 United States of America ‘The device has been manufactured for Carl Zeiss Meditec, Inc. of Dublin, California USA. | This ertifies that the product(s) listed above have been fabricated, assembled, packaged, and documented in accordance with Carl Zeiss Meditec, Inc. (hereby called “CZMI") quality system standards. corresponds with the order The quantity of delivered goods Furthermore, the electrical medical devices provided by CZMI are compliant with IEC 60801-1 for general safety as well as to the collateral standard IEC 60601-1-2 for electromagnetic compatibility as per Essential Requirement of the Medical Device Directive (MDD) 93/42/EEC Annex | | Quality assurance and quality tests comply with ISO 13485:2016. The quality system | of CZMI is certified by the DOS Medizinprodukte GmbH, August-Schanz-StraBe 21, | 60433 Frankfurt, Germany — nolified uncer 0297. Certificate registration No. 250712 | MP2016 and 250712 MDSAP16 Date: 11 December 2018 Quality Management QO Noe i3 Ng Meng Hor Product QualityIN STONNA OLSNIM €V3SH ON 9S1L1-200992 yonpoidg dequinu Wed ‘aouesajes aunyny 4OJ jeENUeW Jesf Ano ul Jays S14} daay aseaid OLEevarPr9z9g Jaquinn 42p40 “ON [eas ayeoyI429 / P| VORA yonpoud Gulmojjo} ay} ayeAoe 0} ]YHU ay} sjuesH ‘ou DELIPay| SS!9Z VED SILIIJIH9D Sudo! HU UK BGLELe-SZL9z98z0OL iq] }uewAaRnUZ414OdX3 GO! AdO €WSH O17 OSL-9S1LL-Z00997 yonpolg daquinu peg “a0uadajad B4NjN4 JO |eNueW 4aSf 4NOA us Jaays sty} deey eseald ll 967802 SZL97982I d8quinNn 48p4iO “ON JEHaS a}e94I9D / P| UOHEAOY yonpoid Hulmojjo} ay} ayeEanoe 0} ]YHuU ay} sjuesH ‘ou OayIpayy Ssi9Z LED a}EdfI}I9D BSuddI7] HANUMAN B80986E-SCL9Z98Z01 $Q] JuswaRHUz0¥8 T3GOW ev JH OM KU ll 1M | vvL9S1 120099200000 yonpoldg sequinn Hed ‘gouasajes eanyny 40} JENUEW 4ES/ 4NOA Ut ooys sIy} deoy aseeid Wa IU Sdw Ainr 2€6290907Z JOqUINN 42PsO. “ON [219g eJeIYIWED / GI UOHeAHIW yonpoud Buymoyjo} ay) aeAnoe 0} 1YSU ayy SyuesB ‘OUI DNPEW Ss!9Z HED a}yedYILED BsuadI] TT rr aun Lidl-Sdw Ainr IM93 WUOWAT NU SONPIW, 150 [90g