Medical Device Manufacturer Catalog No.8017

OROSOL^® can produce medical device – Cardiovascular Life Support & Heart Failure Solutions.

Item Name: OROSOL^® Cardiovascular Life Support & Heart Failure Solutions.

Brand: OROSOL^®

OROSOL^® can produce all kinds of medical devices.

If you are interested in this product, please feel free to contact us: RoboticWorkCell@outlook.com

Product Description

Medical Device Manufacturer Catalog No.8017

General View of OROSOL^® Manufacturer No.8017:

OROSOL Machinery and Equipment Manufacturing LLP is located in China, with Manufacturer No.8017 a modern R&D and manufacturing facility spanning over 10,000 square meters, including nearly 2,000 square meters of Class 10,000 clean workshops and sterile laboratories. The company employs approximately 120-150 professional staff members, with a core R&D team from globally renowned institutions including Imperial College London, University of Maryland, Tsinghua University, and USTC. The company is a National High-Tech Enterprise and National Specialized and Sophisticated “Little Giant” Enterprise, and is the first equity-incubated enterprise of the USTC Advanced Technology Research Institute. The company has established a National Postdoctoral Research Workstation, Provincial Artificial Heart Engineering Research Center, Bionic Medicine Provincial Joint Key Laboratory, and Cardiopulmonary Assist Technology Center. The company has received tens of millions of RMB in funding from High-tech Investment and CAS Investment Fund. The company has been recognized as a National Intellectual Property Advantage Enterprise and a Potential Unicorn Enterprise. The company has obtained over 260 authorized patents among 460+ patent applications, and has been awarded the Geneva International Invention Exhibition Gold Award, Romania IMT Excellence in Research and Innovation Award, and four provincial science and technology awards. The company has successfully developed and launched China’s first domestically produced intra-aortic balloon pump (IABP) system and multiple ventricular assist devices.

Diagnosis, Treatment, and Rehabilitation Equipment for Heart Failure

Product Name & Model	Parameters & Specifications	Features & Applications
OS-TL-IABP-100 Intra-Aortic Balloon Pump	1. Product type: Intra-aortic balloon pump (IABP); 2. Application: Mechanical circulatory support for cardiovascular critical care (acute coronary syndrome, cardiac/non-cardiac surgery, heart failure complications); 3. Operation modes: Navigation and manual modes; 4. Trigger modes: ECG and blood pressure triggers; 5. Display: Touchscreen + physical buttons; 6. Battery: Rechargeable lithium battery for ≥120 minutes continuous operation; 7. Support ratios: 1:1, 1:2, 1:3; 8. Data export: Patient treatment data and system logs (password-protected); 9. User management: Patient information management with treatment history; 10. Safety: Automatic fault detection (blood pressure sensor, catheter disconnect, etc.); 11. Weaning: Automatic weaning program with preset balloon volume, support ratio, and weaning time; 12. Service: Professional after-sales support team.	1. First domestically produced IABP device with full independent intellectual property. 2. Stable, reliable, and easy-to-use design for cardiovascular critical care. 3. Multiple operation and trigger modes for flexible clinical use. 4. Long battery life (≥120 min) for safe patient transport. 5. Automatic weaning program and comprehensive safety features.
OS-TL-EECP-100 Enhanced External Counterpulsation Device	1. Product type: Enhanced external counterpulsation (EECP) device; 2. Application: Non-invasive treatment for cardiovascular and cerebrovascular diseases (coronary artery disease, refractory angina, ischemic stroke); 3. Mechanism: Sequential inflation of cuffs on calves, thighs, and buttocks during diastole to increase aortic diastolic pressure and coronary perfusion; rapid deflation during systole to reduce cardiac afterload; 4. Design: Ergonomic cuff design for improved fit and comfort; large-diameter gas tubing and enlarged air tank for fast response and stable pressure; 5. Control: Self-developed control algorithm for precise timing and enhanced counterpulsation effect; 6. Safety: Multiple protections (arrhythmia detection, heart rate protection, pressure protection, mechanical release protection); 7. Data: Patient information management with hierarchical permission and password protection for data modification/deletion/export; 8. Features: Non-invasive, no complications, easy operation, comfortable treatment experience.	1. Non-invasive external counterpulsation device for cardiovascular and cerebrovascular rehabilitation. 2. Sequentially inflating cuffs improve coronary perfusion and reduce cardiac workload. 3. Recommended by international cardiology guidelines for angina and ischemic stroke. 4. Ergonomic design with precise timing control and comprehensive safety features.
OS-TL-NiCOM-100 Non-Invasive Cardiac Output Monitor	1. Product type: Non-invasive hemodynamic monitor (ICG); 2. Principle: Thoracic impedance method (bioimpedance); 3. Monitoring: Wireless, real-time, continuous monitoring of 16 hemodynamic parameters (cardiac output, myocardial contractility, systemic vascular resistance, etc.); 4. Measurement time: Rapid monitoring (~120 seconds) or extended continuous monitoring; 5. Modes: Static monitoring (cardiology, etc.) and dynamic monitoring (passive leg raise test, etc.); 6. Data management: Data viewing and export for analysis and research; one-key print output (patient info, measurement data, etc.); 7. Features: Non-invasive (no complications, no infection risk); reliable results with good repeatability; correlation with invasive CO monitoring; 8. Applications: Cardiology, internal medicine, pre-surgical cardiac function assessment, rehabilitation, physical examination, emergency/critical care.	1. Non-invasive hemodynamic monitor using thoracic impedance technology. 2. Real-time, continuous monitoring of 16 clinical parameters. 3. Rapid 120-second measurement with reliable, repeatable results. 4. Supports static and dynamic monitoring modes. 5. Comprehensive data management and print functions.
OS-TL-IAB Intra-Aortic Balloon Catheter Kit	1. Product type: Intra-aortic balloon catheter kit (compatible with IABP pump); 2. Components: Balloon catheter kit (balloon catheter, pressure tubing, syringe, helium connector, etc.) + puncture accessory kit (scalpel, needle, guidewire, dilator, sheath with/without side arm); 3. Models: TL-IAB-30 (30CC), TL-IAB-40 (40CC); 4. Catheter diameter: 8 Fr (2.7mm); 5. Materials: Polyurethane balloon (tested to withstand >5 million inflation/deflation cycles); multi-layer central tube and plastic tube for flexibility and support; soft PU tip; hydrophilic coating on balloon for low friction; 6. Features: Two sheath options (standard and with side arm); universal insertion set (direct or sheath insertion); ethylene oxide sterilization; single-use; 7. Benefits: Good trackability, flexibility, reduced complications, smooth insertion, reduced ischemic events.	1. IABP catheter kit for intra-aortic counterpulsation therapy. 2. Available in 30CC and 40CC balloon volumes (8 Fr diameter). 3. Durable polyurethane balloon with hydrophilic coating. 4. Two sheath options and universal insertion set for flexible placement. 5. Sterile, single-use design for patient safety.
OS-TeleVad Series Percutaneous Ventricular Assist Device	1. Product type: Percutaneous ventricular assist device (pVAD); 2. Indications: Cardiogenic shock unresponsive to conventional therapy, high-risk PCI, etc.; 3. Models: TeleVad P50 (design flow 5.0 L/min, for cardiogenic shock); TeleVad P35 (max flow 4.1 L/min, for high-risk PCI/cardiogenic shock); TeleVad RP50 (max flow 4.4 L/min, for right heart failure); 4. Technology: Motor-embedded design; low-hemolysis impeller; micro-motor; advanced anti-coagulation and cooling system; 5. Status: Selected as National Key R&D Program project; under NMPA innovative medical device special review; multi-center clinical trials ongoing; 6. Features: High auxiliary efficiency; low hemolysis; easy operation; minimally invasive; low complication rate; supports hours to days of support (case-dependent); compact and user-friendly; 7. Intellectual property: Full independent intellectual property.	1. Percutaneous ventricular assist device for critical heart failure treatment. 2. Multiple models for left/right ventricular support with flow rates up to 5.0 L/min. 3. Minimally invasive with low complication rates. 4. Advanced low-hemolysis technology and compact design. 5. Nationally recognized innovative medical device.

Certificates of OROSOL^® Medical Device Manufacturer 8017:

ISO 13485:2016 — Medical Devices Quality Management System (Certified)
ISO 9001:2015 — Quality Management System (Certified)
CE Marking (MDR 2017/745/EU) — Compliance with European Medical Device Regulation
NMPA Medical Device Registration Certificate (Class III) — IABP, pVAD (Class III)
NMPA Medical Device Registration Certificate (Class II) — Non-Invasive Cardiac Output Monitor, EECP System
GMP Certification — Good Manufacturing Practice for Medical Devices (China NMPA)
National High-Tech Enterprise Certification (China)
National Specialized and Sophisticated “Little Giant” Enterprise (China)
National Intellectual Property Advantage Enterprise (China)
Potential Unicorn Enterprise (Hefei High-tech Zone)
National Postdoctoral Research Workstation — Ministry of Human Resources and Social Security
Bionic Medicine Anhui Provincial Joint Key Laboratory
National Key R&D Program — “New Generation Intelligent IABP System R&D” project leader
Geneva International Invention Exhibition Gold Award
Romania IMT Excellence in Research and Innovation Award
RoHS Compliant — Restriction of Hazardous Substances Directive (EU)
REACH Compliant — Registration, Evaluation, Authorization and Restriction of Chemicals (EU)