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Mikro Infusionspump - Swemed EU
Mikroinfusionspumpe
3F Annex Hankook Junja Hyeopdong B/D, 114, Gasan Digital 2-ro, Geumcheon-gu, Seoul, KOREA Tel: 82 -2 -858-2839~41 / Fax: 82 -2-858-2442 E-mail: ampall@ampall.com / Website : www.ampall.com Declaration of Conformity *Manufacturer Registered Name: AMPALL CO., LTD. 3F, Annex Hankook Junja Hyeopdong B/D, 114, Gasan digital 2-ro, Geumcheon-gu, Seoul, 08506, Korea (371-51 Gasandong) Tel. +82-2-858-2839 / Fax. +82-505-350-2442 *EC Representative: CE Medical Amerlandseweg 7, 3621 ZC Breukelen, The Netherlands Tel. +31(0)85 007 3220 *Description of Device: - Infusion pump (Model: IP-7700) - Syringe pump (Model: SP-8800) *Relevant EC Directive: Medical Device Directive 93/42/EEC amended by 2007/47/EC Annex 2 *Classification: Class IIb (According to Rule 11) Manufacturer is exclusively responsible for the Declaration of Conformity We herewith declare that the mentioned products above meet the provisions of the Council Directive 93/42/EEC amended by 2007/47/EC for medical devices under the supervision of Notified Body SGS Belgium NV (Notification no. 1639) SGS House Noorderlaan 87 2030 Antwerp Belgium Date : March 09, 2020 1639 President on behalf of AMPALL CO.,LTD. AUTHORIZED AGREEMENT AUTHORIZED AGREEMENT AUTHORIZED AGREEMENT AUTHORIZED AGREEMENT AUTHORIZED AGREEMENT AUTHORIZED AGREEMENT AUTHORIZED AGREEMENT AUTHORIZED AGREEMENT AUTHORIZED AGREEMENT AUTHORIZED AGREEMENT AUTHORIZED AGREEMENTMicrosoft Word 2016