Medical Device Manufacturer Catalog No.8003

OROSOL^® can produce medical device – Dialysis & Hemodialysis Equipment.

Item Name: OROSOL^® Dialysis & Hemodialysis Equipment.

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.8003

General View of OROSOL^® Manufacturer No.8003:

OROSOL Machinery and Equipment Manufacturing LLP is located in China, with production base 8003 a modern manufacturing facility spanning over 45,000 square meters. The company employs more than 750 professional staff members, including a dedicated R&D team of over 150 engineers and technicians specializing in dialysis technology and medical device development. The company has established a comprehensive production base for hemodialysis equipment and related disposables, with products exported to more than 50 countries and regions worldwide.

Medical Device Product Catalog No.8003:

Medical Device Product Catalog No.8003-Hemodialysis Equipment

Product Name & Model	Parameters & Specifications	Features & Applications
OS-W-T2008-B Hemodialysis Device	1. Certifications: Listed in “Excellent Domestic Medical Equipment Product Catalog”; “COVID-19 Prevention and Treatment Essential Medical Equipment Catalog”; Ministry of Science Innovation Fund Project; National Torch Program Project; Major Technical Equipment First Set (Batch) Product; ISO13485, ISO9001, CE certified; 2. Intellectual property: Independent intellectual property rights (invention, utility model, software copyright, etc.); 3. Dialysis modes: Ultrafiltration curve, sodium concentration curve, dialysate curve, bicarbonate curve for personalized therapy; 4. Ultrafiltration control: Closed-loop volumetric balancing chamber for precise ultrafiltration control; 5. Safety monitoring: Self-test on startup, air detection, blood leak detection, dual temperature monitoring, dual conductivity monitoring; 6. Convenience features: One-key priming, one-key low ultrafiltration, one-key drainage, one-key disinfection, timer function, standby liquid-saving mode.	1. Hemodialysis device offering personalized dialysis therapy with multiple curve options for patient comfort. 2. Features closed-loop volumetric balancing chamber technology for precise ultrafiltration control. 3. Comprehensive safety system with multiple monitoring functions (air, blood leak, temperature, conductivity) for patient protection. 4. User-friendly design with one-key operations for priming, low UF, drainage, disinfection, and standby mode. 5. Listed in national excellent medical equipment and COVID-19 emergency equipment catalogs. 6. CE certified with multiple patents and intellectual property rights.
OS-W-T6008S Hemodialysis Device (On-Line HDF)	1. Certifications: Listed in “Excellent Domestic Medical Equipment Product Catalog”; “COVID-19 Prevention and Treatment Essential Medical Equipment Catalog”; Ministry of Science Innovation Fund Project; National Torch Program Project; Major Technical Equipment First Set (Batch) Product; ISO13485, ISO9001, CE certified; 2. Intellectual property: Independent intellectual property rights (invention, utility model, software copyright, etc.); 3. Treatment modes: Hemodialysis, hemofiltration, hemodiafiltration (on-line HDF); 4. Dialysis curves: Ultrafiltration curve, sodium concentration curve, dialysate curve, bicarbonate curve for personalized therapy; 5. Ultrafiltration control: Closed-loop volumetric balancing chamber for precise ultrafiltration control; 6. Safety monitoring: Self-test on startup, air detection, blood leak detection, dual temperature monitoring, dual conductivity monitoring; 7. Convenience features: One-key priming, one-key low ultrafiltration, one-key drainage, one-key disinfection, timer function, standby liquid-saving mode; 8. Optional configurations: Dry powder dialysis, blood pressure monitoring, ultrapure dialysis, remote monitoring.	1. Hemodialysis device offering multiple treatment modes including on-line hemodiafiltration (HDF) for versatile therapy options. 2. Features personalized dialysis with multiple curve options for patient comfort. 3. Closed-loop volumetric balancing chamber technology for precise ultrafiltration control. 4. Comprehensive safety system with multiple monitoring functions (air, blood leak, temperature, conductivity) for patient protection. 5. User-friendly design with one-key operations and optional configurations for expanded functionality. 6. Listed in national excellent medical equipment and COVID-19 emergency equipment catalogs. 7. CE certified with multiple patents and intellectual property rights.

Medical Device Product Catalog No.8003-Hemodialysis Water Production System

Product Name & Model	Parameters & Specifications	Features & Applications
OS-WSL-ROIII/II Series Hemodialysis Water Treatment System	1. Models: WSL-ROIII (three-stage RO technology); WSL-ROII/1, WSL-ROII/2, WSL-ROII/3 (two-stage RO technology); 2. Technology: three-stage reverse osmosis for ultrapure water output; 3. Water recovery rate: Stage 1 >85%; Stages 2 & 3 100% recovery with balanced dilution; 4. Membrane cleaning: High-flow membrane surface flushing with recovered water; 5. Automation: Fully automatic start-up, protection, cleaning, disinfection; standby automatic circulation cleaning; 6. Monitoring: Online conductivity, hardness (optional), chlorine (optional), water shortage, pressure, voltage alarms; 7. Control: Variable frequency control (optional), remote monitoring (optional), data logging; 8. Disinfection: Chemical and thermal disinfection (optional), automatic continuation after power interruption; 9. Standards: YY0793.1-2020, YY0572-2015, AAMI/ASAIO standards; 10. Materials: 304/316L stainless steel, no dead-leg design, no-tank closed-loop circulation; 11. Components: International-grade RO membranes, pumps, controllers; 12. Compliance: GB 4793.1-2007, GB/T14710-2009, EMC compliant.	1. Hemodialysis water treatment system utilizing three-stage RO technology for ultrapure water production. 2. Achieves high water recovery rates (>85% stage 1, 100% stages 2/3) with concentrate recycling for efficiency. 3. Fully automated operation with standby circulation, online monitoring, and optional remote control. 4. Chemical and thermal disinfection options with automatic completion after power interruption for safety. 5. No-dead-leg design with 304/316L stainless steel components prevents bacterial contamination. 6. No-tank closed-loop circulation and ward loop circulation ensure constant water quality. 7. Complies with national and international hemodialysis water quality standards (YY, AAMI/ASAIO). 8. Suitable for multi-bed dialysis centers with reliable, high-purity water supply.

Medical Device Product Catalog No.8003-Hemodialysis Fluid Preparation System

Product Name & Model	Parameters & Specifications	Features & Applications
OS-Hemodialysis Concentrate Preparation System	1. Mixing technology: Vortex rotary stirring for complete A/B powder dissolution; 2. Stirring program: Timed stirring with protection against B-solution over-stirring (prevents bicarbonate loss); 3. Valves: Corrosion-resistant materials for long-term exposure to aggressive liquids; 4. Filtration: Filters remove undissolved particles to meet hemodialysis standards; 5. Disinfection: One-key/fully automatic disinfection with residual concentration verification; 6. Control: PLC automatic control system; 7. Programs: Fully automatic preparation; fully automatic rinsing; one-key disinfection.	1. Hemodialysis concentrate preparation system featuring vortex rotary stirring for complete A/B powder dissolution. 2. Timed stirring program prevents over-stirring of B-solution to avoid bicarbonate loss. 3. Corrosion-resistant valves ensure long service life with aggressive chemicals. 4. Filtration system removes undissolved particles to guarantee concentrate quality. 5. PLC automatic control with fully automatic preparation, rinsing, and one-key disinfection. 6. Designed for centralized dialysis fluid supply systems in clinical settings.
OS-Central Dialysis Fluid Delivery System	1. Control: Centralized control for easy management; 2. Monitoring: Convenient monitoring of dialysate ion concentration; eliminates single-machine preparation errors; 3. Disinfection: System-linked disinfection after daily dialysis; no dead spots; easy detection of disinfectant concentration and residuals; 4. Contamination prevention: Eliminates secondary contamination of concentrate; prepares fresh on-site to reduce biological contamination; 5. Cost saving: Reduces transportation, packaging, and labor costs; minimizes storage space requirements.	1. Centralized dialysis fluid delivery system replacing traditional single-machine preparation methods. 2. Addresses disadvantages of conventional preparation: heavy workload for staff and inconsistent quality. 3. Offers centralized control for streamlined management and consistent quality assurance. 4. Enables real-time monitoring of dialysate ion concentration to ensure accuracy. 5. Features comprehensive disinfection with no blind spots and easy residual concentration verification. 6. Eliminates concentrate secondary contamination risk through on-site preparation. 7. Reduces overall operational costs (transportation, packaging, labor, storage). 8. Ideal for dialysis centers seeking improved efficiency and quality control.

Certificates of OROSOL^® Medical Device Manufacturer 8003:

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
FDA 510(k) Clearance — Hemodialysis Equipment (Class II)
GMP Certification — Good Manufacturing Practice for Medical Devices (China NMPA)
NMPA Medical Device Registration Certificate (Class III) — China National Medical Products Administration
CB Test Report — International Electrotechnical Commission (IEC) Safety Standards
RoHS Compliant — Restriction of Hazardous Substances Directive (EU)
REACH Compliant — Registration, Evaluation, Authorization and Restriction of Chemicals (EU)