BIONIME GM300 - Parts of Critical Component

64
Parts of Critical Component
65
Log Book
Blood Glucose Meter, Test Strip, Control Solution
Manufacturer: Bionime Corporation
694,Renhua Road, Dali Dist., Taichung City 412, Taiwan
Product complied with In Vitro Diagnostic Medical Device Directive 98/79/EC. ( CE0197 )
EC-Rep: Bionime GmbH, Tramstrasse 16, 9442 Berneck / Switzerland
Lancing device
Manufacturer: Bionime Corporation
694, Renhua Road, Dali Dist., Taichung City 412, Taiwan
Product complied with Medical Device Directive 93/42/EEC
EC-Rep: Bionime GmbH, Tramstrasse 16, 9442 Berneck / Switzerland
Disposable Sterile Lancets
Manufacturer:
Product complied with Medical Device Directive 93/42/EEC. ( CE0197 )
EC- Rep:
SteriLance Medical (SuZhou) Inc.
No.68 LiTangHe RD, XiangCheng, SuZhou, JiangSu 215133, P.R. China
EMERGO EUROPE, Molenstraat 15, 2513 BH The Hague, The Netherlands