About Us


About Us

QSEN Medical Technology (Shandong) Co., Ltd


Qsen Med is a professional enterpris especializing in the research, development, and manufacturing of highpolymer medical devices. Headquartered in the High-Tech Industrial Park of Taierzhuang District, Shandong Province, China, we are committed to providing high-quality precision medical components and integrated solutions to medical device brandsand institutions worldwide.

Our modern production facility covers an area of 20 mu (approximately 13,300 square meters), with a total building area exceeding 9,800 square meters. lt includes 4,680 square meters of workshops and raw material & finished goods warehouses over 2,000 square meters of office space, and 3,120 square meters of Class 100,000 cleanrooms (with localized areas reaching Class 1,000 standards). The facility is equipped with Class 7 raw material cleanrooms and Class 5 finished product cleanrooms, along with more than 40 advanced machines including auto-assembly lines for safety syringes, needle assembly machines, sealing machines, and performance testing instruments fully meeting the stringent cleanliness and quality requirements of medical device production.

Our core product portfolio includes:
-Three-way Stopcocks
-Micro Flow Regulators
-Infusion Sets & Accessories
-Drug Mixing Devices
-Luer Connectors, Various Fittings, Protective Caps

All products are made from medicalgrade polymer materials, offering excellent biocompatlblity and sealing performance. They are widely used in clinical infusion, anesthesia, and lCU etc.
Qsen Med is 1S0 13485 certified and holds a Class ll medical device manufacturing license in China. We also operate an ETO (Ethylene Oxide) sterilization service system, registered with the FDA and compliant with ISO11135 standards, ensuring safe and reliable sterilization processes. We bring together a highly experienced R&D and quality management team, with core engineers from leading medical device companies in Europe and China. Our QA team has deep expertise in 1S0 13485, FDA, CE, MDR, and GMP standards, and has established a comprehensive traceability and quality control system to support customers throughout the entire product lifecycle.

Driven by customer needs, we have built a flexible and efficient production and service system that enables rapid response to global clients’customized requirements, ensuring timely delivery and exceptional service.

Qsen Med-Your trusted partner in high-polymer medical device manufacturing.
We welcome your inguiries and look forward to building a successful future together!

408

Components made in house

28 +

Containers capacity per month

95 %

On time delivery

100 %

Traceability guaranteed

QSEN
QSEN
QSEN

Qualification Patent

Qsen Med is 1S0 13485 certified and holds a Class ll medical device manufacturing license in China. We also operate an ETO (Ethylene Oxide) sterilization service system, registered with the FDA and compliant with ISO11135 standards, ensuring safe and reliable sterilization processes. We bring together a highly experienced R&D and quality management team, with core engineers from leading medical device companies in Europe and China. Our QA team has deep expertise in 1S0 13485, FDA, CE, MDR, and GMP standards, and has established a comprehensive traceability and quality control system to support customers throughout the entire product lifecycle.

ISO

ISO

CE

CE

FDA

FDA

GMP

GMP

ANVISA

ANVISA


Acupuncture catgut embedding device

Acupuncture catgut embedding device

Single-use diagnostic therapy puncture kit

Single-use diagnostic therapy puncture kit

Disposable general anesthesia tracheal intubation package tray

Disposable general anesthesia tracheal intubation package tray

Disposable endotracheal intubation bag for general anesthesia

Disposable endotracheal intubation bag for general anesthesia

Disposable catgut embedding needle

Disposable catgut embedding needle

Acupuncture catgut embedding device

Acupuncture catgut embedding device

Single-use diagnostic therapy puncture kit

Single-use diagnostic therapy puncture kit

Disposable general anesthesia tracheal intubation package tray

Disposable general anesthesia tracheal intubation package tray

Disposable endotracheal intubation bag for general anesthesia

Disposable endotracheal intubation bag for general anesthesia

Disposable catgut embedding needle

Disposable catgut embedding needle

Disposable interventional surgical kit

Disposable interventional surgical kit

Disposable umbilical cord clip scissors

Disposable umbilical cord clip scissors

Disposable catgut embedding needle assembly

Disposable catgut embedding needle assembly

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