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Case Achievements

The platform has demonstrated its implementation capabilities in several innovative medical device projects, forming a strong demonstration effect for project transformation.

 

Selected Case Studies:

 

1. Laparoscopic Minimally Invasive Surgery Series

 

Troclose 1200 Series: A globally exclusive Class III innovative medical device, featuring an integrated "puncture-suture" design, filling the technical gap in laparoscopic surgery incision closure. The Lujian Technology & Sichuan Innovation CDMO platform successfully completed the full-chain transformation of the first Class III device in this series, along with NMPA/FDA dual filing.

 

2. Interventional and Implantable Devices

 

(1) Neurovascular Microcatheter - Class III Medical Device

A precision catheter used in neurointerventional surgery, the platform completed its structural optimization, material selection, and process development.

 

(2) Single-Use Tissue Retraction Device - Class II Innovative Medical Device

Used for tissue traction and exposure in minimally invasive surgery, the platform assisted in completing the full process from concept validation to registration filing.

 

(3) Dissolvable Intestinal Blockage External Drainage Device - Class II Innovative Medical Device

An innovative intestinal diversion device, the platform completed the selection of biodegradable materials and process verification.

 

(4) Obstetrics and Gynecology Balloon Catheter - Class II Innovative Medical Device

A balloon dilator used in obstetrics and gynecology surgeries, the platform provided full-chain services from design to production.

 

3. Surgical Instruments

 

(1) Single-Use Tissue Circular Cutter - Class II Medical Device

A precision circular cutting device for surgical procedures, the platform completed engineering sample production and process optimization.

 

(2) Single-Use Catheter Fixation Device - Class II Medical Device

An innovative catheter fixation solution, the platform assisted in product finalization and registration testing.

 

(3) Medical Centrifuge - Class I Medical Device

A centrifuge for laboratory and clinical use, the platform provided electromechanical system development and production services.

 

4. Ethnic Medicine and Specialized Instruments

 

(1) Darika

Modernized improvements to traditional Tibetan medical devices, with the platform completing process standardization and registration filing.

 

(2) Holman

A Tibetan medicine specialty therapeutic device, the platform assisted in transforming traditional instruments into modern medical devices.

 

5. Consumer Healthcare and Diagnostic Equipment

 

(1) Laser Hair Removal Device

A medical beauty device, the platform completed the optical, mechanical, and electrical system integration and production.

 

(2) Contact Lenses

Corneal contact lenses, the platform provided precision manufacturing and quality control services.

 

(3) Bone Conduction Hearing Aids

Innovative hearing assistive devices, the platform completed acoustic structure optimization and registration support.

 

(4) Mobile CT

A portable medical imaging device, the platform assisted with MDR/FDA certification technical support.

 

(5) Bladder Scanner

A urological diagnostic device, the platform provided validation and pilot production services.

 

Currently, the Lujian Technology & Sichuan Innovation CDMO platform has verified its implementation capabilities in several innovative medical device projects, establishing a strong demonstration effect for project transformation. The platform has gradually developed a comprehensive process management system covering R&D design, regulatory consultation, inspection and testing, registration filing, and precision manufacturing. It has achieved international collaboration and innovation resource integration, laying a solid foundation for the efficient implementation of future domestic and international client projects.

Qingdao Lujian Holding Group Co., Ltd

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