CE Certificates
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ISET S.r.l. Sede Legale e Uffici Via Donatori di sangue, 9 - 46024 Moglia (MN) Cod. Fisc. e P.IVA Reg. Imprese CERTIFICATE Certificat - Certificado- Сертификат - Zertifikat - 證書 1) APPLICANT: (who finally puts the product on the market) Shandong Hesource Medical Equipment Co., Ltd. Head Of North Weiyu Road, Liaocheng City, Shandong, China 252000 2) CERTIFICATE NO.: I/ISETC.000920190902 FILE REFERENCE: HS-2019-08-14 3) ISET MARK: 4) CAUTION ABOUT CE MARKING (Instruction for the Applicant who puts the product on the EU market): The label of the CE Marking on the left side should be not less than 5mm height. CE Marking and EC Declaration of Conformity are duties for the manufacturer or its applicant who puts the product on the market. This one is responsible to start the CE marking and certification procedure as required by the legislation in force. Only for the products which are compulsorily included into specific Directives or Regulations will be necessary to appoint a Notified Body. 5) TYPE OF PRODUCT: Series Of Medical Cart MODEL(S): See the following annex I 6) LIST OF DIRECTIVES / REGULATIONS /STANDARDS (as declared by the manufacturer itself) Medical Device Directive 93/42/EEC EN ISO 14971:2012, EN ISO 15223-1:2016, EN 1041:2008 7) NOTE: The applicant is aware about the contents and information included in the ModCOM04.06 Regulation for this type of Certificate that is considered totally accepted. The latest revision of the Regulation is available and can be downloaded from the website www.iset-italia.eu. This document is not referred to any evaluation that could be considered as included in the scope of the activities covered by the standard BS EN ISO/IEC 17065:2012 or European Regulation 765/2008. 8) REMARK: Certificate is issued on voluntary application from the Client and it gives to the applicant the right to use and affix the ISET Mark (at point 3) on their products, even if it doesn’t imply any assessment on the safety and compliance of the product. ISET declares that the only scope of the assessment is to verify the existence of the declaration issued by the manufacturer or an applicant under its own responsibilities. 9) DATE OF ISSUE:02/09/2019 10) SIGNATURE: Li Zhang (On behalf of the Legal representative) This document is property of ISET Srl and any kind of reproduction is to be considered s

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ISET S.r.l. Sede Legale e Uffici Cap. soc. i.v. € 10.200,00 Via Donatori di sangue,9 - 46024 Moglia (MN) Cod. Fisc. e PIVA Reg. Imprese 02 332 750 369

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CE Certificates 2Pages

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CE Certificates
2Pages