LONGKE Medical always adheres to the development concept of in-depth synergistic innovation among production, research and medicine, carries out the development goal of ‘Quality First, Reputation Foremost’, and contributes to the development of China's medical equipments through the establishment of scientific and reasonable medical device R&D personnel training system.
Who We Are
Established in 2021, Liaoning Longke Medical Equipment Co., Ltd. The company's headquarter and R&D base is located in Jinlian New Economic Industrial Park, Shenfu Reform Demonstration Zone, Liaoning Province, with an overall area of 2,000 square metres, including 100,000 purification workshop, biosafety laboratory, active medical device assembly workshop and other specialised R&D and production sites.
In order to meet the national ‘14th Five-Year Plan’ development strategy, accelerate the localisation of China's endoscopy industry, and solve the problem of cross-infection during endoscopic diagnosis, the company firstly focuses on single-use electronic endoscopes, and then focuses on the production of electronic endoscopes. The company firstly focuses on the field of single-use electronic endoscopes.
It took 1 year to independently develop the first single-use electronic bladder and renal pelvis endoscope and electronic endoscope image processor, and at the same time, the domestic core processing chip was perfectly applied to the image processing system, becoming the first enterprise in the Northeast region with independent research and development and production capacity.
Philosophy and Objectives
Development goal: Quality first, reputation first.
Talent Cultivation: Establish a scientific and reasonable training system for medical device R&D talents .
Social Responsibility: Contribute to the development of medical equipment in China.
Business Advantage
The company's headquarter and R&D base is located in Jinlian New Economic Industrial Park, Shenfu Reform Demonstration Zone, Liaoning Province, with an overall area of 2,000 square metres, including 100,000-grade purification workshop, biosafety laboratory, active medical device assembly workshop and other specialised research and development and production sites.
Our workshop
The workshop has clean air-conditioning system, clean water system, high-frequency detection of airborne dust particles, settled bacteria and plankton bacteria. The workshop environment is controlled through high-frequency filtration, timed air exchange and ozone sterilisation, and highly stringent processes and procedures are in place to ensure a high degree of cleanliness in the production environment, such as dye-free, dust-free and sterility-free.
The clean room, a total 400 square metre, is located on the ground floor of the enterprise and is used for the production and assembly of medical devices to ensure that the products comply with the national and industrial standards for medical devices.
Biosafety laboratory
The laboratory is located on the second floor of the enterprise, covering a total area of 100 square meters. It is equipped with an FFU air conditioning system and a purified water system, and has the corresponding testing capabilities to ensure that the products meet the national and industry standards for medical devices.
The facility is equipped with a grade-10,000 positive control laboratory, a grade-10,000 microbial limit laboratory, a grade-10,000 sterile laboratory, an electronic laboratory, a gas chromatography room, and a physicochemical laboratory.
Active Medical Device Assembly Sterile Workshop
The non-sterile assembly workshop is situated on the third floor of the company, spanning a total area of 80 square meters. The workshop interior adheres to electrostatic control standards and is primarily utilized for the manufacturing of medical endoscope image processors, as well as quality testing throughout various assembly stages. It encompasses material zones, assembly zones, welding zones, testing zones, and packaging zones.
Our responsibility
As a medical device manufacturer, safety is the lifeline of product quality.
Safety and Quality
Production process: from R&D verification to manufacturing to final factory inspection
Inspection equipment: more than 30 sets, including optical performance tester, meteorological chromatograph, intelligent safety comprehensive analyser, etc.
Objective: To guarantee the safety and reliability of products
The company is equipped with more than 30 sets of inspection instruments and equipment from R&D verification to manufacturing to final factory inspection. Including optical performance tester, meteorological chromatograph, intelligent safety comprehensive analyser, and other advanced instruments related to biological testing. We can independently complete the experiments and testing of the key performance of the products, which guarantees the reliability of the R&D and the safety of the products.
Research Direction
Sales , Reserve , R&D
Vertical R&D strategy
●Disposable endoscopic catheter
●Automated panoramic endoscopic imaging
●Monocular Multivision 3D Imaging and Measurement Techniques
●Automatic identification technology of urinary stone components
Horizontal R&D strategy
Respiratory endoscopes
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Arthroscopy
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Endoscopy of the ear, ●
nose and throat system
Hysteroscopy
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Development strategy
Committed to becoming the national leader in disposable flexible tube endoscopes
2023
Marketplace >>
- Obtained the first medical device registration certificate
- Obtained ISO13485 medical device quality management system certification Initial sales of products in the market
- Completed the layout of urological endoscopy intellectual property rights
2024
Market Development >>
- Improve the medical device registration model
- Formation of the initial sales scale of the product
- New product research and development is completed and sent for inspection
- Approved as national high-tech enterprise
- Apply for EU CE certification Overseas market layout
2025
Market Occupation >>
- Obtained new product medical device registration certificate
- Urological products market share into the national top five
- Apply for U.S. FDA certification
2026
Industry Leadership
- Obtained the registration certificate of innovative medical devices related to disposable endoscopes
- LONGKE Medical became a famous enterprise in the field of endoscopy in China.
