Catalog excerpts
This is to certify that the quality system of: Yung Kang Medical Device Technology Co., Ltd. No. 142, Sec. 3, Yunke Rd., Douliu City, Yunlin County 640, Taiwan For design, production and final product inspection/testing of: SUCTION COLLECTION SYSTEM Has been assessed with respect to: THE CONFORMITY ASSESSMENT PROCEDURE DESCRIBED IN ANNEX II EXCLUDING SECTION 4 OF COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES, AS AMENDED and found to comply. Further details of the product(s) and conditions for certification are given overleaf. Place and date: Hovik, 19 January 2021 For: DNV GL PRESAFE AS Notified Body No.: 2460 /orte Tone Elise Kolpus PROD 021 The cGrtific:ate is digitally verified by blockchain technology. For more info, see www,dnvqi.-.CQm/g?5urgncg/cgrtifiC9tes-in-thg-biockchaifirhtrni Notice: The Certificate is subject to terms and conditions as set out in the Certification Agreement. Failure to comply may render this Certificate invalid. NOTIFIED BODY: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Hovik, Norway - Registered Enterprise No: NO 997 067 401 MVA .
Open the catalog to page 1Certificate No.: Project No.: Valid Until: Jurisdiction Application of Council Directive 93/42/EEC of 14 June 1993, adopted as "Forskrift om Medisinsk Utstyr" by the Norwegian Ministry of Health and Care Services. Certificate history: EU Representative COMERCIAL HISPA, S.A., C/ Aeronautica, 11, 28923 Alcorcon, Madrid, Spain NOTIFIED BODY: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Hovik, Norway - Registered Enterprise No: NO 997 067 401 MVA .
Open the catalog to page 2Certificate No.: Project No.: Valid Until: Terms and conditions The certificate is subject to the following terms and conditions: ■ Any producer (see 2001/95/EC for a precise definition) is liable for damage caused by a defect in his product(s), in accordance with directive 85/374/EEC, as amended, concerning liability of defective products. ■ The certificate is only valid for the products and/or manufacturing premises listed above. ■ The Manufacturer shall fulfil the obligations arising out of the quality system as approved and uphold it so that it remains adequate and efficient. ■ The...
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