About Us

Ascentet Group Co., Ltd

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

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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

2012 - Ascentet Group Inc established in Hong Kong
2015 - Ascentet Industrial Limited Company set up in Shanghai
2015 - Ascentet Inc branch office set up in New York
2020 -Hunan Xunzhuo Industry Co., Ltd with factory set up
2020 - Ascentet Medical Equipment in Shanghai with factory set up
2021 - Ascentet Medical Equipent in Hubei with factory set up
2021 - Medline Medical Technology Co., Ltd in Hunan with factory set up
2021 - Ascentet brand of medical products set up

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.

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Professional team

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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

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Production line for non-sterile products

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Production line for non-sterile products

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Production line for non-sterile products

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Production line for non-sterile products

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IVD production line

6

Production line for sterile products

7

Production line for sterile products

8

Production line for sterile products

 

Plant environment test report

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Production and testing equipment

More than 100 production and testing equipment to meet commissioned production, inspection and testing

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Electric pressure steam sterilizer

2_1

Fabric water permeability tester

3_1

Gas chromatograph

4_1

Purified water equipment

5_1

Protective clothing anti synthetic blood penetration tester

6_1

Electric constant temperature incubator

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Electric drying box

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Air volume meter

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Electric blast drying oven

10_1

Ultra clean worktable

11_1

Conductivity meter

12_1

One in 100000 electronic balance

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Electric pressure steam sterilizer

Inspection room and laboratory

Nearly 10 medical device professional inspection rooms and laboratories

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Passive Laboratory

26

Active laboratory

33

laboratory

42

Physical and chemical laboratory

53

Microbial limit room

Ethylene Oxide Sterilization Center

800 Square meter for EO sterilization workshop

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