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CE certificate
1 /2Pages

CE certificate

CE certificate
1 /2Pages

Catalog excerpts

CE certificate-1

Manufacturer: Yung Kong Medical Device Technology Co., Ltd. No. 142, Sec.3, Yunke Rd., Douliu City, Yunlin County 640, Taiwan European Authorized Representative: Lotus NL B.V. Koningin Julianaplein 10, le Verd, 2595AA, The Hague, Netherlands. We hereby declare that the below mentioned devices comply with the European Medical Device Regulations (EU) MDR 2017/745 and be carried out according to the Quality Management System EN ISO 13485:2016. The EU declaration of conformity is issued under the sole responsibility of the manufacturer. Product Name: GMN/Basic UDI-DI: Risk class: Conformity assessment procedure: Relevant Harmonized Standards: Suction Liner (Product Specifications List As attachment) 471987332YKSG001ZQ Class I, Non-sterile, no measuring function and not surgical instrument, (according to rule 1 set out in annex VIII of Regulation (EU) 2017/745) Art. 19, Annex II and Annex III according Regulation (EU) 2017/745 (MDR)

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  1. GMP

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  2. ISO 13485

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