bslEU Quality Assurance Certificate Reg u lation {EU) 2017/745, A nnex XI te rt A MDR Manufacturer: Changzhou Centrau Medical Instrument Ca,Ltd. {Building 5)Nq.5, Hexiang Road Jiangsu Wujin Etnnomic Development Zone Changzhou 215000 China Single Registration Number: <1 EU Authorised Representative: Phoenix Medtech GmbH Address: Koenigdje rger Etrasse 11 64039 Muenster Hessen Germany <S Scope: see attached Device Schedule On the basis of our examination of the quaity system in acosidanee with Regulation (EU] the quality system meets the requirements of the Regulation. For the placing on the mart devices an additional AnnexX certificate is required. for and on behalf ol Bit, a Notified Body tor the above Regulation {Notified Body Numb* 2797): Graeme Tin bridge, Senior Vice President Oobal Regulatory it Quality First issue Date: ZD 25-07-13 Client Issue Date: 2025-07-18 Starting Validity Date: 2025-07-18 Expry Date: 2030-07-17 making excellence a habit' Page 1 of 4 VzfcHf of ti3 cotfcdle is ccndcicnd cn 1he HanLrbcij-ixi quaity sysiem bang marfianed So 5he requra-nai® dT ihe IriegJadcn an da-rensraid trou^i ihe rajured scryalbnce acMia off the Notified Body: Ths coif cafe wea imued Hecnntzd^- aid e bound by ihe andicra dihe artract ISIS Ccnfec: fi&l Gnup The L^heHaTct 6X £ay £l Jcing, Jdn LH. fepapfem % ]«6 B* SfcEhertsnds. Tdi: +■ 31 00} 20 346 07SO Ccrpciafse CaTSitt Iflfil Gratca AsLrancE _irr*ed, reepTred n Inlaid under nentsa- 0S4l£t£t4O afi 3S9 Gisuvck Ife^i ftoad, _cndon. Wf -ML, UK. A MkJilMi otfihe l5£i C-raMP of Garpanes.

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