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Open a medical zoom endoscope to obtain a medical device registration certificate

Shanghai Securities News China Securities Network News (reporter Zhang Liang) opened medical on the afternoon of the 26th issued an announcement that one of the company's medical device products has been approved by the Guangdong Provincial Drug Administration, and recently obtained the Medical Device Registration Certificate of the People's Republic of China, the certificate approval date is January 19, 2022, the effective date is January 19, 2022, and the validity period is January 18, 2027.

According to the announcement, the zoom endoscope is used to observe the changes in fine structures such as glandular canal openings, microvessels and capillaries on the surface of the mucosa of the digestive tract, which is conducive to judging the pathological nature of mucosal lesions, clarifying the invasion range of lesions and improving the accuracy of biopsy, which has unique advantages in gastrointestinal diseases, especially in early tumor diagnosis.

Kaili Medical said that the company's variable focus endoscopic EG-550Z, a gastroscope with optical magnification function, realizes the zoom observation of the details of the lesion within a 3mm object distance. It can achieve 85 times the image magnification, and at the same time, combined with the SFI and VIST special light staining modes of the company's light source, doctors can clearly observe the mucosal surface, submucosal capillary morphology and glandular canal opening morphology, so as to preliminarily determine the nature of early cancer.

Open a medical zoom endoscope to obtain a medical device registration certificate

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