Haiye Medical
Haiye Medical
Explore our primary commercial products engineered for high-definition airway management, diagnostic bronchoscopy, and advanced image processing capabilities.
Founded in 2013, Haiye Medical has evolved into a internationally recognized biomedical engineering powerhouse specializing in the R&D, custom manufacturing, and global exportation of advanced video endoscopy platforms. Operating at the intersection of optoelectronic instrumentation, precision mechanics, and digital signal processing, Haiye delivers custom OEM/ODM solutions to medical device distributors, hospital syndicates, and industrial diagnostic providers across more than 40 countries.
Our core technical portfolio encompasses state-of-the-art video laryngoscopes, fiber optic laryngoscopes, video stylets, single-use and reusable flexible video endoscopes, electronic bronchoscopes, disposable digital ureteroscopes, multi-functional medical camera processing units, and high-intensity LED cold light sources.
By integrating vertically integrated manufacturing with rigorous quality management protocols—certified under ISO 9001, ISO 13485, CE (MDR), and US FDA registrations—Haiye guarantees clinical-grade imaging precision, structural reliability, and flawless regulatory compliance for our global OEM partners.
Advanced R&D and Precision Cleanroom Manufacturing at Haiye Medical
Understanding global market transformations: Transitioning from traditional rigid optical trains to single-use micro-CMOS flexible platforms and AI-driven diagnostic image engines.
Hospital-acquired infections (HAIs) and cross-contamination concerns have accelerated the worldwide adoption of single-use bronchoscopes, ureteroscopes, and disposable video laryngoscopes. Haiye’s OEM manufacturing lines provide sterile, cost-optimized single-use solutions that eliminate reprocessing overhead while offering equal high-definition optical resolution to traditional reusable scope systems.
Modern surgical requirements demand outer distal tube diameters under 2.8mm without sacrificing optical field-of-view (FOV) or depth of field (DOF). Our OEM engineering teams utilize chip-on-tip sensor integration, packaging 400,000+ pixel CMOS sensors into ultra-compact distal tip housings alongside fiber optic or high-intensity LED light guides.
Raw visual signals require sophisticated real-time signal enhancement. Haiye’s proprietary Image Processors (such as the HY-TS13 and HD3B systems) leverage FPGA digital architecture to offer narrow-band chromatic rendering, edge sharpness optimization, noise reduction, and high-dynamic-range (HDR) tissue visualization.
Haiye Medical does not simply manufacture off-the-shelf devices; we co-engineer specialized optical, mechanical, and electronic sub-assemblies for medical device brand owners globally. From tailored outer sheath articulation angles and hydrophobic lens coatings to white-label GUI software design and customized housing colors, our OEM exporter workflow is designed to accelerate your time-to-market while reducing regulatory overhead.
Since our founding in 2013 in the Huyi District of Xi'an, Haiye Medical has continuously expanded its research capabilities, automated production machinery, and global market reach. By combining specialized mechanical manufacturing with modern micro-electronics, we offer comprehensive solutions tailored to emergency medicine, anesthesia, ICU intubation, urology, pulmonology, and veterinary surgery.
Our dual-center strategy—combining strategic marketing and engineering hubs in Xi'an with advanced electronics integration facilities in Shenzhen—enables flexible, high-volume production while maintaining rigorous compliance with medical device manufacturing standards.
Haiye Medical was officially established in Huyi District, Xi'an, focusing initial core R&D on direct and indirect optical airway visualization instruments.
Secured formal State Class II Medical Device Manufacturing Licenses, establishing standardized ISO cleanroom assembly protocols.
Established centralized international sales and commercial headquarters in downtown Xi'an to manage expanding global distributor networks.
Exhibited complete video laryngoscope and flexible bronchoscope suites at MEDICA Düsseldorf, launching international OEM exporting channels.
Established dedicated subsidiary in Shenzhen to capitalize on cutting-edge micro-CMOS image sensor engineering and electronic component integration.
Official opening of modernized technical center at Taihuabei Road, Xi'an, housing specialized optical testing laboratories and global customer support teams.
Acquired a new manufacturing plant dedicated to expanding single-use sterile flexible scope cleanrooms and high-speed automated testing rigs.
We maintain independent design, tooling, optical alignment, and cleanroom assembly operations, allowing complete cost optimization and zero-defect quality control across every batch.
Haiye Medical maintains full regulatory compliance to ensure seamless product registration, customs clearance, and clinical distribution for our OEM partners worldwide.
| Regulatory / Engineering Parameter | Haiye OEM Standard Protocol | Custom OEM Option / Partner Flex |
|---|---|---|
| Quality System Standard | ISO 13485:2016 Certified / ISO 9001 | Audit-ready facility access for partner QA checks |
| International Approvals | CE (EU MDR 2017/745), US FDA 510(k), NMPA Class II | Full technical file support for local country registration |
| Cleanroom Class | Class 100,000 (ISO Class 8) Certified Cleanrooms | Custom sterile packaging (EtO Sterilization validation) |
| Optical Resolution | Full HD (1920x1080) to Ultra HD 4K digital output | Micro-CMOS custom signal processor mapping |
| Biocompatibility Compliance | ISO 10993-1, ISO 10993-5, ISO 10993-10 Compliant Materials | Custom surgical grade stainless steel or medical polymer sheath |
| Ingress Protection Rating | IPX7 / IPX8 Fully Submersible Design | Custom seal testing for chemical high-level disinfection |
Our versatile endoscopy architectures are deployed in emergency clinical settings, surgical operating rooms, outpatient clinics, and specialized non-destructive testing environments.
Hyperangulated video laryngoscopes and slender video stylets designed for ICU and Anesthesia teams to manage obstructed or difficult patient airways with high first-pass success rates.
Single-use and reusable flexible bronchoscopes featuring high articulation angles (up to 210° up/down) for precise BAL, biopsy, and bronchial lumen inspection.
Ultra-slim digital flexible ureteroscopes designed for retrograde intrarenal surgery (RIRS) and renal calculus fragmentation with maximum irrigation channel diameter.
Ruggedized reusable endoscopic systems engineered specifically for small animal gastroenterology, avian rigid scope procedures, and equine upper respiratory exams.
How Haiye Medical is leading the transition toward AI-guided lesion enhancement, wireless endoscopic transmission, and sub-millimeter optics.
Integrating real-time deep-learning computer vision models directly onto OEM image processor FPGA boards for automatic tissue anomaly highlight and polyp detection during diagnostic procedures.
Pioneering sub-millimeter distal chip placement for pediatric bronchoscopy, micro-otoscopy, and peripheral vascular inspection using wafer-level optics (WLO).
Developing ultra-wideband (UWB) uncompressed 4K video signal transmission protocols to remove cable tethers between insertion tubes and surgical display consoles.
Explore our full line of specialized clinical scopes designed for diverse surgical, diagnostic, and veterinary applications.
Expert answers regarding custom engineering options, regulatory transfer documentation, minimum order quantities (MOQs), and global shipping logistics.
