Tianyi medical: Guotai Junan Securities Co.Ltd(601211) about the listing recommendation of the company’s initial public offering and listing on the gem

Guotai Junan Securities Co.Ltd(601211)

about

Ningbo Tianyi medical device Co., Ltd. issued shares for the first time and was listed on the gem

of

Listing recommendation

Sponsor

No. 618, Shangcheng Road, China (Shanghai) pilot Free Trade Zone

April, 2002

Guotai Junan Securities Co.Ltd(601211)

About Ningbo Tianyi Medical Instrument Co., Ltd

Shenzhen Stock Exchange:

Guotai Junan Securities Co.Ltd(601211) (hereinafter referred to as “the institution”, “sponsor” or ” Guotai Junan Securities Co.Ltd(601211) securities”) accepted the entrustment of Ningbo Tianyi medical device Co., Ltd. (hereinafter referred to as “Tianyi medical”) to act as the sponsor of its initial public offering of shares and listing on the gem (hereinafter referred to as “the offering”). The sponsor appointed Shen Yichong and Shui Yaodong as the sponsor representatives specifically responsible for recommending the offering.

The law of the people’s Republic of China on initial public offerings (hereinafter referred to as “the securities law of the people’s Republic of China”) and the “measures for the administration of initial public offerings” (hereinafter referred to as “the securities law of the people’s Republic of China”) The measures for the administration of securities issuance and listing recommendation business (hereinafter referred to as the “measures for the administration of recommendation”) and other laws and regulations, as well as the relevant provisions of the CSRC and the exchange, shall be honest, trustworthy, diligent and responsible, issue the recommendation letter for listing in strict accordance with the business rules and industry self-discipline norms formulated according to law, and ensure that the documents issued are true, accurate and complete.

Unless otherwise specified in this listing recommendation, relevant terms have the same meaning as in the prospectus of Ningbo Tianyi medical device Co., Ltd. for initial public offering and listing on GEM.

catalogue

1、 Basic information of the issuer four

(I) overview of the issuer four

(II) main business four

(III) core technology and R & D level five

(IV) main business and financial data and indicators nine

(V) main risks 12. II. The issuer’s current offering 3. Sponsor representatives, Project Co sponsors and other project team members of this securities issuance and listing thirty-one

(I) the sponsor representative specifically responsible for this recommendation thirty-one

(II) Project Co sponsors and other project team members 31 IV. relationship between the sponsor and the issuer V. commitments of the sponsor thirty-three

(I) general commitment to the sponsor of this listing thirty-three

(II) item by item commitment to the sponsor of this listing thirty-three

(III) the recommendation institution and the recommendation representative make a special commitment to Vi. decision making procedures for the performance of this securities issuance 34 VII. Explanation on whether the issuer meets the positioning of the gem 35 (I) the company does not belong to the industry that does not support the application for issuance and listing on the gem in principle 35 (II) innovation, creativity and creative characteristics of the company; The company’s scientific and technological innovation, model innovation and business type innovation

And the integration of new and old industries 35 VIII. This issuance meets the issuance conditions stipulated in the securities law 37 IX. the issuer meets the listing conditions specified in the measures for the administration of initial registration on the gem 38 X. This issuance meets the issuance conditions stipulated in the Shenzhen Stock Exchange GEM Listing Rules 43 Xi. Recommendation conclusion of the sponsor on this issuance 44 XII. Specific arrangements for the continuous supervision of the issuer’s securities after listing 44 I. Basic information of the issuer (I) overview of the issuer

Ningbo Tianyi Medical Instrument Co., Ltd

English Name: ningbotianyi Medical Appliance Co, Ltd.

The registered capital is 44210526 million yuan

Legal representative: Wu Zhimin

Date of establishment: March 12, 1998

Address: No. 788, Mozhi North Road, Dongqian Lake Tourist Resort, Ningbo, Zhejiang

Postal Code: 315121

Zhang Chongliang, head of information disclosure of Securities Department of the Ministry of information disclosure and investor relations

Tel.: 057455011010

Fax No.: 057488498396

Company website http://www.tianyi-med.com./

E-mail [email protected].

Manufacturing, processing, wholesale and retail of class I, class II and class III medical devices; Manufacturing, processing, wholesale and retail of disinfection products; Manufacturing, processing, wholesale and retail of plastic products, rubber products, metal products and mechanical accessories; Manufacturing, processing, wholesale and retail of pharmaceutical packaging materials; Wholesale and retail of chemical raw materials (excluding hazardous chemicals); Disinfection and sterilization services and technology research and development; The business scope is engaged in technology development, technical consultation, technical service and technology transfer in the field of medicine and medical device science and technology; Technical services of medical devices; Daily mask (non-medical) production; Daily mask (non-medical) sales; Self operated and acting as an agent for the import and export of all kinds of goods and technologies, except for the goods and technologies restricted or prohibited by the state. (for projects subject to approval according to law, business activities can be carried out only after approval by relevant departments)

(II) main business

The company is a high-tech enterprise mainly engaged in the R & D, production and sales of medical devices such as medical polymer consumables in the field of blood purification and ward nursing. It is one of the early enterprises focusing on this field in China and has a strong brand influence. The main products include extracorporeal circulation blood circuit of blood purification device, disposable arteriovenous puncture device, disposable integrated oxygen inhalation tube, feeder and liquid feeding tube, etc.

As of the issuance date of this listing recommendation letter, the company has obtained 24 Chinese medical device registration / filing certificates, including 17 class II medical device registration certificates and 7 class III medical device registration certificates.

In addition, the company

Through the FDA enterprise filing, some products have passed the EU CE certification and FDA product listing. The company has passed the EN ISO 134852016 quality management system certification.

Since its establishment, the company has been focusing on the R & D, production and sales of medical devices such as medical polymer consumables, accumulated rich experience in R & D, production and operation, and has a highly automated production line and a perfect quality assurance system. After years of development, the company’s products cover 31 provinces, municipalities and autonomous regions in China, and are exported to Asia, Europe, North America, South America, Africa and other countries and regions. According to the relevant research report of frost Sullivan, according to the product sales ranking, the company ranked second in the market share of cardiopulmonary bypass in China in 2019. (III) core technology and R & D level

1. Core technology

The company attaches great importance to technology research and development. After more than 20 years of research and development investment and practice accumulation, the company has rich product design and production experience. In the process of production and operation, according to market demand and user feedback, the company continues to improve process technology and new product research and development, and continuously improve product performance and production efficiency. The core technology of the company belongs to integrated innovation and introduction, absorption and re innovation. The main core technologies of the company are as follows:

Core technology core technology and advanced technology and specific characterization technology, operation category, source of operation name

6mm and 8mm inner diameter design is adopted to ensure the stability of pump pipe flow and pressure

Qualitative and can match with different peristaltic pumps; Select the scientific proportion through repeated tests

For the PVC raw material of the pump pipe, after the temperature resistance test of this part at 0 ~ 50 ℃, and under the normal temperature automatic meter technical state, the pump pipe is subjected to 0 ~ – 250 mmHg (0kpa ~ 33.3 kPa) arterial systolic pressure, and the flow deviation after continuous operation at 200ml / min for 24 hours is not greater than

10%, without fission, the blood flow of hemodialysis is stable

Fixed, higher than the industry average.

Using rigid PVC as raw material to improve impact toughness; Realization of high precision die

The tolerance of components shall be controlled within 50 μ Within m, ensure that it is under the water pressure of 150kPa (row)

The product design standard is 100KPA), and the water barrier breathable film and welding parts shall be kept for 1 hour without leakage

Leakage and rupture of pressure measuring technology; The waterproof and breathable membrane adopts imported double-sided membrane to ensure water resistance and permeability, and the design of independent parts is 0.5 of the air. μ The filtration rate of particles above M is greater than 90%. At the same time, under the R & D technical air pressure of 7 kPa, the air flow of the diaphragm is greater than 0.13l/cm2 to ensure the speed of pressure transmission

Rapid response to pressure changes during dialysis to ensure the safety and effectiveness of treatment

Effectiveness.

The ozone gas with the concentration of 2-3ppm is prepared by using the independently developed ozone generator,

Ozone is used to sterilize the purified water and the inner wall of the bottle. The sterilization technology without adding any bacteriostatic agent is independent bacteria technology, which is ahead of the sterilization technology adding bacteriostatic agent and preservative in the industry, and has higher R & D safety.

The multifunctional design of the special oxygen inlet and outlet protective cap and the design of the air inlet are equipped with filter holes

The inlet and outlet gas diameter is 0.22 μ The design of m water blocking ventilation filter membrane, automatic check valve for outlet outlet and design of self opening port, dynamic pressure relief start, etc., effectively prevent the external environment from polluting the liquid in the bottle and the burst caused by the high pressure of the bottle technology, and leads the industry in similar products in terms of advanced design.

It has better convenience and safety.

The pore size distribution of microcrystalline gas is 10-25 μ M bubble generator, oxygen passing through

The air inlet duct of bubble generation enters the pores of the foaming device, which greatly improves the contact time and area between oxygen and water, and effectively improves the humidity in oxygen. Under the maximum working flow of 8.33l/min and the minimum working flow of 5L / min, the humidification output can reach 8.5mg/l (industrial standard)

The opinion is 7Mg / L), which ensures the comfort and safety of treatment.

Through robust design and miniaturization of injection mold, the injection mold maintains high precision and high stability of injection parts

On the basis of precision, realize the number of multi holes of the mold, improve the production efficiency of injection molding products, the dimensional accuracy of independent densification technology and batch stability; For example, in the 48 hole mold, the R & D accuracy of each hole product can be controlled within 0.05mm, and the dimensional stability of more than 88% can reach CPK

≥ 1.67, Cpk higher than the requirements of industry standards ≥ 1.33.

The high-speed and high-speed injection molding machine adopts full electric high-speed injection molding machine, and the whole process servo Ma Dajin is used in the mold locking process

Precise injection line control to ensure the position response of 0.05mm; The moving speed of the screw in the injection process can reach 200 mm / s and the repetition accuracy can reach 0.1% ~ 0.15%; Optimize the R & D and technical structure of crankshaft structure, and control the accuracy of die opening position at 0.01mm; Ensure the injection molding accuracy of the product and repeat

The dimensional error of miscellaneous injection molded parts can be within 0.05mm.

Injection molding zero fold injection port adopts more efficient ultrasonic welding technology, and the welding can be completed within 2.5s

The parts are super connected and formed, which is far less than about 5S of traditional hot melting; Welding products have strong firmness and can

Acoustic welding ensures ventilation of 30psi and no leakage for 15s, which is much higher than that of industry technology

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