Ayzeze: Dieses Gerät ersetzt keine ärztliche Beratung, Diagnose oder Behandlung. Bei Zweifeln sollte vor der Nutzung ein Arzt konsultiert werden. Der Verkäufer/Vertreiber übernimmt keine Haftung für Schäden, die durch Fehlgebrauch, eigenmächtige Modifikationen oder nicht bestimmungsgemäße Verwendung verursacht werden.
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The Yuwell 590 is a high-precision, code-free blood glucose meter designed for easy and accurate blood sugar monitoring at home or in clinical settings. It features an automatic coding system, a large screen with backlight for clear readings, and provides quantitative detection of glucose in capillary or venous whole blood. This kit includes the main instrument, 50 test strips, and 50 lancets for immediate use.
Product Technical Requirement Number: Su械 Zhunzhun 20172220309
Medical device name: Blood Glucose Meter
Is the inventory managed by lot number?: yes
Structure and composition: The blood glucose meter consists of a main unit, a lancing device (optional), a power cord (optional), and a power adapter (optional).
manufacturer: Jiangsu Yuwell Kailite Biotechnology Co., Ltd.
Code setting method: Fully automatic code-free
National subsidy registration model: 590
Units of measurement: set
Production license or filing certificate number: Su Yao Jian Xie Production License No. 20220081
category: Finger prick blood test
Medical device category: Class II 22
Medical device registration certificate number or filing certificate number: Su械 Zhunzhun 20172220309
Storage conditions: Ambient temperature range: 5°C~40°C; Relative humidity range: 10%-85%; Atmospheric pressure range: 70Kpa~106Kpa
Scope of application: This product is a self-testing in vitro diagnostic medical device for blood glucose monitoring and is used in conjunction with blood glucose test strips manufactured by Jiangsu Yuyue Kailite Biotechnology Co., Ltd. It is used in hospitals and homes for quantitative determination of glucose concentration in capillary whole blood or venous whole blood.
Registrant or filer information: Jiangsu Yuwell Kailite Biotechnology Co., Ltd.
Domestic/Imported: Domestic
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