A Medical Device Daily
China Sky One Medical (Harbin, China) reported the receipt of CE-mark certification for its myocardial infarction and urine microalbumin diagnostic kits.
The company also received ISO 9001 and ISO 13485 certifications for its myocardial infarction, urine microalbumin and early pregnancy diagnostic kits. The two ISO certifications are valid through October 2014.
“We are honored to receive the CE marking and the ISO certifications, which reinforce the high quality of our products and manufacturing standards and pave way for exporting the diagnostic kits in the EU and other markets,“ said Yan-Qing Liu, CEO/chairman of China Sky One Medical. “According to agreements with our distributors in Indonesia, Turkey, Singapore and Vietnam, we will enter into definitive contracts with the distributors following receipt of the CE marking. The CE marking and ISO certifications also strengthen the company's ability to advance our negotiations with potential distributors from many other countries. We look forward to launching our diagnostic kits in promising international markets beginning in 2010.“
China Sky One Medical is a holding company. The company engages in the manufacturing, marketing and distribution of pharmaceutical, medicinal and diagnostic products.
The CE marking certifies that the two products have met the European Union (EU) health and safety standards and are approved for sale in the 27 EU countries and four members of the European Free Trade Association (EFTA).
Menicon acquires lens manufacturer Tomey
Menicon (Nagoya, Japan) said that it had acquired all shares of Tomey from Tomey Shoji (also Nagoya).
Tomey is a manufacturer of contact lens care solutions, soft contact lenses, and RGP materials, and has been in operation since 1971. Tomey has been the contracted supplier to Menicon of contact lens care solutions, and the exclusive supplier of Menicon monthly replacement soft contact lenses, and latheable RGP and soft lens materials including Menicon Z, Menicon EX, Menisoft and Menicon Soft 72. Menicon said this acquisition enables it to control the manufacture of its lens and lens care products, and will strengthen its competitiveness in Japan as well as in the global markets.
Tomey will be renamed MeniconNect. A former director of Tomey, Hirofumi Minamikawa, was named as MeniconNect's president, with Tokiyasu Tsuchida of Menicon named executive VP of MeniconNect. Together, they will form a new management team to steer the company as one of the Menicon group companies. All former Tomey employees will remain in MeniconNect and the manufacturing facilities will stay as they are.
“Menicon is very pleased to complete, through this acquisition, the vertical integration of manufacturing and material procurement into operation. Having complete control of manufacturing operations will help us provide even better products and services, and excellent value to all our customers in Japan and around the world. This will certainly help us accelerate our global business expansion,“ said Hidenari Tanaka, president of Menicon.