SIUI Lr Declaration of Conformity Manufacturer Shantou Insitute of Utrasonc Instruments Co, Lid ‘Adress 477, dosha Road, Shantou, 615061 Guangdong, PEOPLE'S REPUBLIC OF CHINA European ‘Sangha Intemational Holding Corp. GmbHEurope) Represeniaive Eifecrasse 0, 20537 Hamburg Germeny Product Category Metical Utrasonc Diagnostic Systems Models aus 60 Intetgent Breast Utrasound System Classication la based on MDD 93142/EEC annex IX rule 10 ‘The UMONS code 14276 Segment ode MD 1202 Conformity Assessment Foute Annex without section 4 Identtcaion Number 0°23. ‘We deca the compéance ofthe above medical dvi vith the apptcabe requirements ‘of Medical Device Directive: COUNCIL DIRECTIVE 93/42/EEC OF 14 JUNE 10903 CONCERNING MEDICA. DEVICES (MOD 89/42/EEC). A tho supporting documents and fes are retained under the premises ofthe manufactures. ‘We ave exchsivalyresponsibie fo the Declaration of Conformity. Notiled Body: TOV 800 Product Service GmbH, Rdlestrasse. 65, ‘90399 Munchen, Germary, Cortical: Gt 051640 O18 Rev.08 ‘Start of CE-Marking: Not yet. Signature: ate: 2020-10-20 — Psion: President Place: Shantou foie eeunmaienr7® sion) Tolese-orsesosoiso MIPS REG NRA Ermallsnesuicom Htpiwwmsicomen Fox see-oetsogexce, “enn tmencrmnnn