Company Introduction
Ascentet Group Co., Ltd (Hong Kong) has a factory in Hunan Province. It is the first medical device registrant system integration platform in Hunan Province under the guidance of Hunan Food and Drug Administration, and the only CDMO platform in Xiangtan Hunan Medical Device Industrial Park.
commissioned production platform. CMO platform is a pure third-party commissioned production platform, which has been built to meet the requirements GMP and ISO13485 requirements 10,000, 100,000 production lines 30, and more than 100 sets of production and testing equipment, to meet the requirements of sterile, non-sterile, IVD diagnostic reagents, software and other products commissioned production requirements. At the same time, it is also equipped with public laboratories, public cold storage, public hazardous compounds warehouse, ethylene oxide sterilization center, etc., which can realize shared production.
About Us
Hong Kong based company specializing in Medical supplies, epidemic prevention supplies, medical instruments and equipment
Has offices in Hong Kong, Shanghai , New York, Hunan, Hubei
Products currently manufactured in China
18 years of experience in Medical supplies and furniture
History
Company Lisence
Our company has the production licenses for 10 different major categories of medical devices, including active, sterile, and IVD production forms, and has obtained ISO13485 certification in 2020.
The active clean workshop is 2,400 m2, sterile clean workshop for class 100,000 is 4,200 m2 , the IVD class 10,000 clean workshop is 1,500 m2, the EO sterilization workshop is 800 m2, and the logistics warehouse is 1,000 m2, totaling 9,900 m2.
Professional team
System management personnel
8 people with professional medical related discipline background and senior industry experience.
Technical staff
12 people with professional medical related discipline background and senior industry experience.
Sterile、Non-sterile、IVD production line
More than 30 GMP-compliant production lines、 Class 10,000 and 100,000 clean workshop required by ISO13485
Production line for non-sterile products
Production line for non-sterile products
Production line for non-sterile products
Production line for non-sterile products
IVD production line
Production line for sterile products
Production line for sterile products
Production line for sterile products
Plant environment test report
Production and testing equipment
More than 100 production and testing equipment to meet commissioned production, inspection and testing
Electric pressure steam sterilizer
Fabric water permeability tester
Gas chromatograph
Purified water equipment
Protective clothing anti synthetic blood penetration tester
Electric constant temperature incubator
Electric drying box
Air volume meter
Electric blast drying oven
Ultra clean worktable
Conductivity meter
One in 100000 electronic balance
Electric pressure steam sterilizer
Inspection room and laboratory
Nearly 10 medical device professional inspection rooms and laboratories
Passive Laboratory
Active laboratory
laboratory
Physical and chemical laboratory
Microbial limit room
Ethylene Oxide Sterilization Center
800 Square meter for EO sterilization workshop