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Jul 01,2022
On January 10, 2023, Wantaifu Biotechnology received CE certification for six of its in vitro diagnostic products from the European Union. The certification is a recognition and affirmation of the quality of Wantaifu's products by international authoritative organizations. The six products that passed the certification are as follows:
S A R S - C o V 2 A n t i g e n T e s t ( N a s a l S w a b )
S A R S - C o V - 2 & I n f l u e n z a A / B A n t i g e n C o m b o R a p i d T e s t K i t ( N a s a l S w a b )
S A R S - C o V - 2 & F l u & R s v A n t i g e n C o m b o R a p i d T e s t K i t ( N a s a l S w a b )
H . P y l o r i A n t i g e n R a p i d T e s t C a s s e t t e ( F e c e s )
F e c a l O c c u l t B l o o d ( F O B ) R a p i d T e s t C a s s e t t e ( F e c e s )
M u l t i - D r u g O n e S t e p S c r e e n T e s t P a n e l ( U r i n e )
"CE" certification
1 ►The passing of the "CE" certification marks a new level of product quality for Wantaifu Biotechnology, and adds a strong pass for the company's products to enter the international market. The "get out" strategy is of great significance.
2 ►Wantaifu's IVD business is looking to expand overseas and the European Union is a key area for it. The business has already obtained CE certification for many products, which reflects the quality, safety and effectiveness of Wantaifu's products as affirmed by the notified body. This also demonstrates that Wantaifu has the ability to meet the regulatory requirements and standards in various regions. This move will strengthen Wantaifu's determination to enter overseas markets and accelerate the internationalization of its IVD business.
Ask:
What aspects of work do medical device companies need to do to successfully pass CE certification:
Answer:
One: The company collects technical regulations and EN standards related to certified products in the European Union and incorporates them into its enterprise product standards by digesting and absorbing them.
Two: The company strictly organizes production according to the above product standards, meaning that it implements the requirements of the technical regulations and EN standards into the entire process of product design, development and manufacturing.
Three: Enterprises must establish and maintain quality systems according to ISO9001+ISO13485 standards and obtain ISO9001+ISO13485 certification.
About Wantaifu
Located in the state-level economic development zone---Hangzhou Bay Biotechnology Park, Xiaoshan Economic and Technological Development Zone, it is a biotechnology enterprise dedicated to the research, development, production and sales of rapid diagnostic reagents and health care products.
Zhejiang Wantaifu Biotechnology Co., Ltd. was registered in May 2022 with a registered capital of 30 million yuan and a total investment of 100 million yuan. It currently has 126 employees.
And built a research and development center and production workshop with 10,000-level automated production lines, which provide effective guarantees for high-precision, high-sensitivity, wide-linearity, and high-efficiency products. It is not only convenient for customers to flexibly customize precision consumables, Design and processing, while ensuring the continuous supply of the supply chain.
With its advanced production technology and a perfect management system, Wantaifu Biotechnology has amassed a wealth of practical experience and research and development technology in the field of colloidal gold rapid diagnostic products. It strictly implements the quality management system standards in the product production process and carries out thorough inspections to strengthen process control. This ensures that only qualified products leave the factory, thereby increasing product market share and customer satisfaction.
