Manufacturer: Yung Kang 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 Canister (Product Specifications List As attachment) 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) Report No. : YK-TCF-SB018 rev. AO0 Page 1/2 Pages
Open the catalog to page 1Directions : (1). r j the canister is used for with shut-off filer liner ; r j the canister is used for without shut-off filter liner. (2). r Suction canister j : for use with suction liner and trolley. Applicable to the suction driven by a central gas system.(3). r Second generation suction canister j : the canister is integrated with a slide block.Report No. ■ YK-TCF-SB018 rev. A 00
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