Announcement on Sun Company Observing Medical Device Registration Certificate and Medical Device Production License
Time:2020-03-23
Classification: Company Announcement
Shouhang High-Tech Energy Technology Co., Ltd. (hereinafter referred to as the "Company") invested in the establishment of wholly-owned Sun Company Shouhang Clean Energy (Quanzhou) Medical Technology Co., Ltd. (hereinafter referred to as "Shouhang Medical") on February 10, 2020, for the production and sale of medical masks to alleviate the domestic virus protection needs.
The Company received notice from Shouhang Medical on March 21, 2020, and Shouhang Medical has obtained the Medical Device Registration Certificate and the Medical Device Production License approved and issued by the Fujian Provincial Drug Administration.
The relevant information is as follows:
I. The contents of the certificate are as follows
1. Medical Device Registration Certificate
Name of registrant: Shouhang Jieneng (Quanzhou) Medical Technology Co., Ltd.
Registration Certificate No.: Min Machinery Note 20202140177
Domicile of the registrant: No.1, Shanjiao, Zhuyuan Village, Merrill Lynch Sub-district Office, Nanan City, Quanzhou City
Production Address: Floor 1 and Floor 2, No.1, Shanjiao, Zhuyuan Village, Merrill Lynch Sub-district Office, Nanan City, Quanzhou City
Product name: disposable medical mask
Model: sterile type flat ear hanging, sterile type flat strap, sterile type folding ear hanging; Non-sterile type flat ear hanging, non-sterile type flat strap, non-sterile type folding ear hanging
Specifications: large, medium, small
It is a non-sterile type, sterile type.
Scope of application: for all kinds of clinical personnel to wear in the process of non-invasive operation, covering the user's mouth, nose and jaw, to prevent pathogens, microorganisms, particles and other direct through to provide a certain physical barrier.
Date of Approval: March 18, 2020
Valid until: June 17, 2020
This product is an epidemic emergency approval product, the registration certificate is valid for three months (such as the end of the epidemic). Enterprises in the renewal of registration, should be in accordance with the "medical device registration management approach" requirements to improve all registration information.
2. Medical Device Production License
Company: Shouhang Jieneng (quanzhou) Medical Technology Co., Ltd.
License No.: No. 20200512 Xu, Production of Fujian Pharmaceutical Supervision Machinery
Domicile: No.1, Shanjiao, Zhuyuan Village, Merrill Lynch Sub-district Office, Nanan City, Quanzhou City
Production Address: Floor 1 and Floor 2, No.1, Shanjiao, Zhuyuan Village, Merrill Lynch Sub-district Office, Nanan City, Quanzhou City
Legal Representative: Huang Qingle
Person in charge of the enterprise: Huang Qingle
Production scope: Class II 14-14 medical personnel protective equipment
Issuing time: March 18, 2020
Term: until 17 June 2020
II. Impact on the Company
Based on the emergency needs of epidemic protection, the company Sun's first flight medical through the green approval channel to obtain the "medical device registration certificate" and "medical device production license." After the relevant qualifications are approved, the company will be able to produce medical protective masks to meet the needs of domestic and foreign epidemic protection, product sales will have a positive impact on the company's revenue and profits.
According to the relevant regulations, before the expiration of the above license, the company can continue to apply for extension or supplement the relevant information, apply for the formal "medical device registration certificate" and "medical device production license", then if the successful acquisition will not affect the company's follow-up related protection normal production and continuous operation.
According to the company's layout of the production of masks, in the above-mentioned mask production line put into production at the same time, the company actively promote the construction of marketing channels at home and abroad.
III. Risk Tips
1, the business for the company's new intervention in the business there is a lack of production and operation experience, the risk of increased competition in the future, in addition, due to the current epidemic in the global fermentation, masks and other protective materials are still in short supply, mask production will be affected by raw material supply market price fluctuations and other factors, there is a risk of unstable sources of raw material supply. Please pay attention to investors.
2, as masks belong to the current market in urgent need of protective equipment, the investment is expected to have a certain positive impact on the company's operations, but the mask production industry competition is more, there is a risk of increased competition in the future and thus affect operating efficiency, please investors pay attention to the risk.
IV. Documents for Reference
1. Medical Device Registration Certificate
2. Medical Device Production License
It is hereby announced.
Shouhang Gaoke Energy Technology Co., Ltd.
Board of Directors
March 23, 2020