Guo Rui Xin Chuang
1. Company Profile
Shaanxi CREATRON Medical Technology Co., Lrd is an independent, third-party preclinical efficay and safety evaluation research facility for medical devices. It was registered and established in June 2020 in Konggang New City and is currently the most comprehensive medical device safety evaluation facility in Northwest China. The company primarily provides product safety evaluation services to R&D enterprises specializing in Class II and Class III medical devices.The company primarily provides product efficacy and safety evaluation services for R&D enterprises engaged in Class II and Class III medical devices.Its business scope includes preclinical safety evaluation, bio-sample analysis, and pathological studies. Moreover, the company’s medical device efficacy and safety evaluation research supports the synergistic integration of the “innovation chain-industrial chain” in the life sciences sector under the Qin Chuangyuan initiative, thereby boosting the development of the province’s life sciences industry.
2. Medical Device Laboratory
 |  |  |
Anesthesia room | Surgical Site Environment | Medical Device Operating Room |
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Instrumental equipment | ||
3. Instrument&Equipment
• 450 sets of professional instruments and equipment
• Automatic blood analyzer
• Automatic biochemical analyzer
• Automatic blood clots
• Automatic urine analyzer
• Automatic dehydrator
• Automatic dyeing machine
• LC/MS-MS
• Artificial heart-lung machine
• DSA digital subtraction angiography machine
……
4. Qualification Certificate
5. Medical Device Testing Items
Serial number | Project Name | Serial number | Project Name |
1 | Transcatheter Aortic Valve Replacement (TAVR) | 21 | Peripheral Drug-Eluting Balloon Angioplasty Catheter |
2 | Transcatheter Mitral Valve Replacement (TMVR) | 22 | Inferior vena cava filter |
3 | Transcatheter Tricuspid Valve Replacement | 23 | Cardiac pacemaker |
4 | Transcatheter Pulmonary Valve Replacement (TPVR) | 24 | Intraoperative stent system |
5 | Transcatheter Mitral Valve Repair System | 25 | Interventional Covered Vascular Stent |
6 | Transcatheter Tricuspid Valve Repair System | 26 | Large Vessel Mesh Stent |
7 | Implantable Left Ventricular Assist Device | 27 | Anti-embolism cerebral protection device |
8 | Left Ventricular Assist Device under Extracorporeal Circulation | 28 | Intracranial vascular stent for thrombectomy |
9 | Interventional Left Ventricular Circulatory Support System | 29 | Intracranial vascular aspiration catheter |
10 | Left atrial appendage occluder | 30 | Intracranial vascular drug-eluting balloon catheter |
11 | Cryotherapy Ablation Catheter | 31 | Biodegradable bone screws |
12 | Radiofrequency ablation catheter | 32 | Vascular malformation embolization coil |
13 | Electrical Pulse Ablation Catheter | 33 | Hemostatic material |
14 | Coronary drug-eluting stent | 34 | Absorbable surgical sutures |
15 | Coronary Drug-Eluting Balloon Catheter | 35 | ICE Ultrasound Diagnostic Catheter |
16 | Coronary Rotablation Catheter | 36 | Chronic heart failure model in large animals |
17 | Coronary Artery Ultrasound Balloon Catheter | 37 | Large animal aneurysm model |
18 | Coronary biodegradable stent | 38 | Large Animal Aortic Calcification and Stenosis Model |
19 | ECMO | 39 | Large animal mitral regurgitation model |
20 | Pulmonary thrombectomy device |
6. Scope of Business
1.Core Regulatory Study Services
We provide comprehensive, compliant, and high-quality preclinical study solutions to support medical device registration in key global markets, including China (NMPA), the United States (FDA), and the European Union. Our services strictly adhere to international quality standards such as GLP.
Services include:
• Preclinical animal studies and reports for NMPA, FDA, and EU (OECD GLP) regulatory submissions.
• In vitro simulation platform testing and reporting for both R&D and registration stages.
2.Integrated R&D Support Platform
We offer full-cycle R&D support from proof-of-concept to product finalization. Leveraging our specialized animal models and testing platforms, we accelerate your product development process.
Services include:
• Preclinical large animal studies and product optimization reports for the device development phase.
• Establishment of innovative large/small animal models (e.g., for myocardial infarction, heart failure).
• Medical device testing utilizing ex-vivo organ models.
3.Clinical & Industrial Translation Services
We bridge the gap between laboratory research and clinical application, providing comprehensive translation support to physicians and innovative companies from concept to product.
Services include:
• Clinical trial protocol development and consulting based on preclinical data and physician input.
• Technical training on device clinical application and medical knowledge courseware development.
• Industrialization services for physician innovations, including patent conversion support.
• Training on novel clinical techniques.
4.Strategic & Evaluation Support
We provide independent third-party evaluation and strategic consulting services for medical device projects, supporting companies in project initiation, financing, and securing government R&D funding.
Core services include:
• Independent evaluation reports for project initiation, investment due diligence, and grant applications.
• Collaborative application support for national, provincial, and regional innovation grants.
7. Typical Cases
Serial number | Client | Trial project |
1 | Shanghai [Company Name] Medical Device Company | TAVR Aortic Valve Replacement Surgery |
2 | Shanghai [Company Name] Medical Device Company | II. Implantation Surgery for the Mitral and Tricuspid Valve Clips and System |
3 | Shanghai [Company Name] Medical Device Company | Left atrial appendage closure procedure |
4 | Shanghai [Company Name] Medical Device Company | PFA Atrial Fibrillation Feasibility Acute Animal Study |
5 | Shenzhen [Company Name] Medical Device Company | Peripheral/Intracranial/Coronary Drug-Eluting Balloon Implantation Procedure (including pharmacokinetic analysis) |
6 | Thrombectomy Trial Using a Suction Catheter in Combination with Microcatheters and Guidewires | |
7 | Suzhou [Company Name] Medical Device Company | Coronary stent implantation surgery |
8 | Hangzhou [Company Name] Medical Device Company | Electrophysiological Catheter Intervention Animal Safety Study |
9 | Suzhou [Company Name] Medical Device Company | II. Animal Study on Implantation of a Tricuspid Valve Repair Device in Pigs |
10 | Suzhou [Company Name] Medical Device Company | Aortic Valve Replacement Surgery (Transcatheter/Transapical) |
11 | Suzhou [Company Name] Medical Device Company | Transcatheter Aortic Valve Replacement via the Apical Approach |
12 | Shandong [Company Name] Medical Device Company | Coronary Stent Balloon Catheter Implantation Procedure |
13 | Sichuan Chengdu [Company Name] Medical Device Company | Animal Study on Transcatheter Aortic Valve Implantation in Pigs |
14 | Xi'an [Company Name] Medical Device Company | Construction of Heart Failure Models and Implantation of Atrial/ Ventricular Catheters |
15 | Xi'an [Company Name] Medical Device Company | Intracardiac Ultrasound Catheter Intervention Animal Study |
16 | Xi'an [Company Name] Trading and Medical Equipment Co., Ltd. | Sheep ECMO Extracorporeal Membrane Oxygenation Model Experiment |
17 | Xi'an [Company Name] Bio-Company | Oral bone/membrane regeneration implant surgery |
More fields
As an institution in Shaanxi Province that has obtained NMPA drug GLP certification and completed its qualification re-examination and scope expansion in 2024, Guorui Yinuo has built a “global + domestic” dual-compliance service capability in the pharmaceutical sector.
The one-stop service platform for veterinary drugs—GLP/GCP—is a specialized service provider that offers an integrated solution—from non-clinical evaluation to clinical trials and registration submission—aligned with both the Ministry of Agriculture and Rural Affairs’ GLP/GCP standards for veterinary drugs and the international OECD GLP standards, covering the entire R&D process for veterinary pharmaceuticals. At its core, this platform addresses the key pain points faced by companies, including long R&D cycles, high compliance barriers, and fragmented resources.
As the only organization in the Northwest region to have obtained OECD GLP certification in the pesticide field, Guorui Yinuo passed the international assessment with a zero-defect record. Relying on its compliance credentials, comprehensive technological capabilities across the entire value chain, and high-standard laboratory platform, Guorui Yinuo provides integrated solutions for global pesticide companies—from research and development all the way through registration.
Relying on the OECD GLP zero-defect certification qualification, chemical test data can be globally recognized and simultaneously comply with both domestic and international chemical regulatory requirements as well as relevant requirements of the Ministry of Ecology and Environment, efficiently supporting needs such as chemical registration and export declarations.
Shaanxi Guorui Xinchuang Medical Technology Co., Ltd. is an independent, third-party clinical preclinical safety evaluation research institution for medical devices. It was registered and established in June 2020 in the Airport New City and is currently the most comprehensive medical device safety evaluation institution in Northwest China. The company primarily provides product safety evaluation services to R&D enterprises specializing in Class II and Class III medical devices.
A full-process technology empowerment platform from target discovery to IND submission
Early Toxicity Prediction and Screening
Early toxicity screening is an essential and indispensable step in the new drug development process. Early termination of compounds that show no development potential can save sponsor substantial amounts of manpower, resources, and time. We offer sponsor comprehensive early toxicity screening services, including early genotoxicity assessment, early general toxicity assessment, and early reproductive and developmental toxicity assessment.
We are equipped with specialized instruments and devices, including flow cytometers, microplate readers, fluorescence microscopes, and PCR machines. These resources enable us to establish animal models for diseases affecting the tumor, cardiovascular, respiratory, metabolic, and urinary systems, and to conduct comprehensive and systematic preclinical studies on drug efficacy and mechanisms at multiple levels.
Contact phone number
Ms. Li:+86 15760970681
Mr. Su:+86 19991001701
Landline:+86-29-33656828
Company Address
4th Floor, Unit C. Building 9. Small and Medium-sized
Enterprise Park, Airport Industrial Zone Airport New Ciy,Xixian New Area, Shaanxi Province
©2026 Xixian New Area Guorui Yinuo Drug Safety Evaluation and Research Co., Ltd.
WhatsApp：8613940397353
Email：hr-xian@grglp.com
Landline：862933656828
Mr. Su：8619991001701
Ms. Li：8615760970681