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Dect of Coo DECLARATION OF CONFORMITY (Manufacturer's Delration) Manufacturer: 'SBO Hearing A'S ‘Kongebakken 9 DK-2765 Sarum Denmark ‘Telephone +4839 17 71 00 Fax 64539277900 Single Risation Number (SRN): DK-MF-000001270 “This dectaation of conformity i issued under the sole responsibilty of SBO Hetrng AS. “The following Common Specifications) are used to declare this conformity: NA The Manafatire hereby declares tha the listed mica devioes are in conformity withthe essential requirements and other relevant rouleaens of the following Dsetives and Regulations: [EU Medical Device Regulation (MDR)2017/745 To fulfil the European requirements concerning medical devices, the manufacture has established a full quality assurance system as described in Annex IX ofthe MDR for clas ln deve excluding not, Spplicale sections) supported by EC certificate G10 003348 0003 (with related product ist) esd by he “Manufacturer's Noted Body (NB) 0123 TOV SOD Product Service ib, Rierstasse 68, 80339 ‘Munich, Germany {EU Radio Favinment Directive (RED) 2014/S¥/EU Conformity assessment to Article 3 Essential, Requirements performed by SBO Hearing AVS. EV RoHS Directive 201 /6EU and amendment Commision Delegated Dis ‘amending Annex ILto Directive 201 16S/EU and applied Standard LEC 65000:2016 Conformity {seannet to restriction ofthe use of certain hazards substances inclestal and electronic exuipment directive inclading ll applicable amendments performed by SBO Hearing A, ‘Signed in Smorum 2022-08-10 on behalf of SBO Hearing A/S fornx 'SBO Hearing A'S CE ons ‘BO Hearing A/S "Tel EU NOR BRS aT Coty Clas Ta G6 Faarng, HOUR Rer 20 Page Tata Dect of Cony Medial devices covered by tis declaration of conformity: el Dee Dep) ‘ican On IC ‘Brand | __ Basle UDEDI SS tao Seer oN a cumomice |S WT peor Se er eh oe i ae Se BE care Haba an crassa Se ore aie a Breit Sera ENS Sey eriaianraee eee eerie ceoomima [Steere Seperate set Eaee com Owe 1 TC ‘Oma FRIFICTOTS ‘nm 2, KIT 10 NEMO PB ‘Onn, KE 1090, ‘Own 2, KIT 10 NEMS PD ‘Oom KIT 1075 PB (Gon? KIT 1090 P5 ‘Own 2, KIT 10 NFMI7S un 2, IT 10 NEMO. ‘Own 2 KIT312 246 NEMO PE (Own 2 IT312 240 NFM PB. ‘Own2, KIT312 240 NIM 90 (Own 2, KIT 312240 NIM re08 Own tT (Own RIT 312 NEM 90 PB ‘Own2, KIT 312 NEM PB ‘Oma 2 RIT 312 NEM 90 | | ‘Own KIT 312 NFM (un KITS12 NEL, ‘Own 2, KIT 312 246 NEMO PB (Own 2, KIT 312 24G NEM PS ‘Own, KIT 312 24G NEM 90 (Own, KIT 312 24GNFM con wn21TE HS | Onn 2:KIT312 NFN(9O PB (scon On 2TTEFS ‘Own2, KIT 312 NFM PD (Onm2, KIT 312 NEN 90 ‘Onna, AIT 312 NIM. (Own 2 KIT 312 24GNFMR l Own 2 KIT 312 NMR. ‘Teague EU WOR Canales of Cooly Gast la S60 Fasing, SHMOO Fe. EO Pana ‘ticon Own 216 ofcon | s7ieteco.H-0676.RW ican Omn2C1C Dectaton of Canty ‘Owe SEINIC OTS Own 3 RITE 1099 ‘Oa 3, KIT IO NFATS ‘Own 3x17 1090, (Onn 3, KIT 1075 nn KIT 1090 8 (Own KIT 10 NFS Ps ‘On, KIT 10 NFM 90 PB (Own, KIT 10 NFO ‘Own, KIT 1075 ‘Owe 3 KIT 312 240 NEMO PB (wn 3KIT 3122.46 NEM PB (we 3 KIF 312240 NEM. (wn 3 KIT312 246 NFM9D (Own 3 KIT312 NEM ‘ton Owns HC con Own 3 IC ‘kon Own 311 (Onn 3, RIT312 NFM OO ‘Own 3 KIT312 24G NM OOPD (On 3 RIT312.240 NFM PB. ‘On, KITS12 NPWS ‘On KIT312 NFO PR fon On 3 TERS 3 ‘Onn, KIT312 NPM. et ‘Own, KIT312 24G NEM (wn 3 KIT 312 NERE90. wn 3,KIT 3122.46 NEM 90 (wn 3:KIT 312246 NEM. ‘Owe FRITH TOTS Own 4 RITE 1090 ‘Owe 4 KIT 1O PACTS (On RIP 1075 (Oa KIT 10 NPA 90 FB Onn KIT 1075 9 nn RIT 1090 (Owe RIT 10 NEMS PB ‘Onn KIT 1ONEMSO_ ‘Own KITT12 246 NFO ‘Ov KIT312 24GNEM PB. (Own KIT312 24G NEMO ‘Own KIT312 246 NFM (we KIT 312 NENE90 PB (Own KIT312 NEN PB ‘vn. KIT312 NFM 90 wn RIT312 NEM ‘Own KIT S12 246 NEMIOO PS ‘Own KIT312 240 NFM PB (Own, KIT312 246 NIM9D con Own ITE HS (Owe KIP312 246 NEM. Ofcon Own ITE FS (On KIT312 NFM 90 PS ‘Ona 4 KITS12 NPM PB ‘Onn 4 RIT312 NIM 90 (Onn KIT312 NEM con Own IC tion Own 417 ‘Gra SEETTICIOTS ‘Own KITIIC 1090 ‘Owe, KIT 10 NFAIOD ‘On, KIT 1ONFM90 PB "Talas or C0 WOR Ovcran cf Cnty iss Ta ~ SE Vang, SSE SOOG ar 20 Pap od ‘ton Own SC ‘tion Own SIC ects of Contomiy ‘Gan 5 KIT TOTS PH (Onn KIP 1090 8 ‘Onn RIT 10 NFM75 PB ‘Own KIT 1090 Own KIT 1075 ‘Owe 5 KIT312 240 NEN(OOPE (wn KIT 3122.46 NEMS (Owe 3 KIT 312246 NEMO (Owe 5 KIT 312 2.40 NEW (5 KIT 312 NPM9O PB (Oe 5 KIT 312 NEM ‘mn 5 KIT 312 NPM 90 (Onn 5, RIT 312 NEM. ‘Own 5,KIT312 246 NEMSO FS ‘Onn KIT312 24GNFMPR (Onn 5/KIT312 246 NFM9D (on Ove ITE HS ‘Ons, KIT312 24GNEM (son Own SITES ‘Own KIT 312 NEMO PE (wn KIT 312 NEM PB. (wn 8 KIT 312 NEMO (wn $ KET 312. NEM fon Own TC "Fas EU OR BESTA oT CON Clas GSE Pang, BETO AE Rae ZO Pasar

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