EXCLUSIVE SALES AGENCY AGREEMENT

EXCLUSIVE SALES AGENCY AGREEMENT

Declaration of Conformity

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Mikro Infusionspump - Swemed EU

Mikroinfusionspumpe

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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 AGREEMENT