Product Name:Hematology Analyzer
Product Model :HF-3800
Product Type:This product belongs to the medical electrical equipment
1.According to the nation’s management and classification to the
medical equipment it belongs to IVD medical equipment.the
management classification is Ⅱ.
2.According to medical electrical safety classification it belongs to
Class I ordinary equipment.
Registration Information:Shandong FDA registration certificate for medical device
No.20120063
Medical Instrument Registration Certificate:Shandong FDA registration certificate for
medical device permit 2014 No. 2400436
Product Standard:YZB/LU 0166-2010.
Product Scope: mainly used for blood cell analysis of whole blood or pre-diluted blood in
medical clinical