Securities code: Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) securities abbreviation: Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) Announcement No.: 2022011 Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932)
Announcement on the company’s Automatic Coagulation Analyzer obtaining the medical device registration certificate
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete without false records, misleading statements or major omissions.
Changsha Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) (hereinafter referred to as “the company”), a wholly-owned subsidiary of Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) (hereinafter referred to as “the company”), recently obtained a class II medical device registration certificate issued by Hunan drug administration. The specific contents are as follows:
1、 Product information
Serial product name validity period expected use registration certificate No. product diagram
Claim
This product adopts coagulant
Full automatic 2022 solid method, immune Turbidimetry
Blood coagulation will arrive on the 28th of the month, and the chromogenic substrate will be approved by Hunan machinery
1 analyzer 2027 2 method, used for blood 20222220378
On 27th, cl3000, coagulation and anticoagulation were performed
Coagulation, fibrinolysis and antifibrinolysis
Analysis of solubilization function.
2、 Impact on the company and risk tips
The automatic coagulation analyzer cl3000 adopts coagulation method, immunoturbidimetric method and chromogenic substrate method, which are used in combination with the supporting kit to analyze the functions of blood coagulation, anticoagulation, fibrinolysis and antifibrinolysis. The analyzer is an in vitro diagnostic medical equipment that can realize multi person and multi item continuous detection. The test process is automatic, the operation is simple, rich and practical.
Cl3000 is a medium-sized Automatic Coagulation Analyzer with simple and convenient operation experience. The original tube is directly put on the machine and the track is automatically and continuously injected. The external independent emergency position is convenient for faster detection of emergency samples. All Chinese touch screen all-in-one machine, one key start, automatic maintenance and repair. The cuvette can be poured randomly and automatically arranged. Cap puncture to improve biosafety.
Automatic Coagulation Analyzer cl3000 is the first certified product of the company’s coagulation product line, enriching the company’s in vitro diagnosis product line, improving the company’s core competitiveness and market expansion ability, and is expected to have a positive impact on the company’s future business results. The actual sales of the above-mentioned products are affected by many factors, such as, etc. at present, the company is unable to predict the specific impact of the above-mentioned products on the company’s future operating revenue. Please pay attention to the investment risk. It is hereby announced.
Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932)
Board of directors
March 25, 2022
