企業(yè)概況
長春市醫(yī)用高分子有限公司始建于2000年,建筑面積8800平米。現(xiàn)有產(chǎn)品:X射線造影劑注射裝置(高壓注射器)、一次性使用高壓造影注射器及附件、醫(yī)用膠片、一次性使用無菌陰道擴張器。
我公司是經(jīng)國家認可的專業(yè)生產(chǎn)“一次性使用高壓造影注射器及附件”的十幾家生產(chǎn)企業(yè)之一,是國家食品藥品監(jiān)督管理局在吉林省唯一一家定點生產(chǎn)“一次性使用高壓造影注射器及附件”的生產(chǎn)廠家。在新的《醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范》發(fā)布后,公司于2010年7月按照新的《規(guī)范》要求,對生產(chǎn)車間、檢驗室、原材料外協(xié)件庫、滅菌間、解析庫等進行了改造。改造后十萬級凈化車間面積2010.5平米,檢驗室面積144平米,原料外協(xié)件庫351平米,滅菌車間204.75平米,解析庫426.4平米。同時根據(jù)《規(guī)范實施細則》要求,重新建立了質(zhì)量管理體系,并形成文件。
公司的檢驗室設(shè)備齊全,公司的質(zhì)檢部具有以上產(chǎn)品的檢測控制能力。我公司具有優(yōu)秀的技術(shù)團隊,公司正在不斷的開發(fā)新產(chǎn)品,擁有更好地服務(wù)。
Changchun Medical High Polymer Co., Ltd. was founded in 2000, with a construction area of 8,800 square meters. Our products is including: X-ray Contrast Medium Injection Device (high-pressure syringe), disposable high-pressure contrast syringe and accessories, medical film, disposable sterile vaginal dilator.
Our company is one of the ten manufacturers with national Accredition specializing in the production of disposable high-pressure contrast syringes and accessories, and the only one fixed manufacturer designated by the state food and drug administration to produce disposable high-pressure contrast syringes and accessories in jilin province. After the announcement of the new "medical equipment production quality management standards", in July 2010, according to the requirements of the new "standards", the company transformed the production workshop, inspection room, raw material outsourcing parts warehouse, sterilization room and analytical warehouse. After the renovation, the 100,000 grade purification workshop covers an area of 2010.5 square meters, the inspection room covers an area of 144 square meters, the raw material outsourcing parts warehouse covers an area of 351 square meters, the sterilization workshop covers an area of 204.75 square meters, and the analytical library covers an area of 426.4 square meters. At the same time, according to the rules for the standardization of implementation, the quality management system has been re-established and documented.
The company's inspection room is well equipped, and the company's quality control department has the ability to test and control the above products. Our company has excellent technicians team, the company is constantly developing new products and with better service.