Haiye Medical Haiye Medical

OEM/ODM Medical Endoscope Factories & Exporters

Empowering Global Healthcare Distributors & Hospital Supply Chains with ISO 13485 & CE/FDA Certified Micro-CMOS Optical Visualization Systems

Featured Clinical Visualization Portfolio

High-resolution single-use and reusable video endoscopes engineered for anesthesia, emergency medicine, pulmonology, and critical care.

HYHJ-1320 Disposable Video Laryngoscope
HYHJ-1320 Disposable Video Laryngoscope
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HYHJ-KC Reusable Video Laryngoscope
HYHJ-KC Reusable Video Laryngoscope China Factory and Suppliers
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HYHJ-KP Series Disposable Video Laryngoscope
HYHJ-KP Series Disposable Video Laryngoscope
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HY-HG5.2 Video Stylet
HY-HG5.2 Video Stylet
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Disposable Veterinary Endoscope
Disposable Veterinary Endoscope
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HY-TS13 Endoscope Image Processor
HY-TS13 Endoscope Image Processor
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SingleUse Digital Flexible Bronchoscope HYYZQ Series
SingleUse Digital Flexible Bronchoscope HYYZQ Series
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HighPerformance Electronic Bronchoscope
HighPerformance Electronic Bronchoscope (2026 Edition)
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10+
Years R&D Excellence
40+
Global Countries Exported
100%
ISO 13485 & CE Compliance
50+
OEM/ODM Custom Projects

Strategic Industry Overview: The Paradigm Shift in Medical Endoscopy Manufacturing

The global medical endoscopy market is undergoing an unprecedented structural transformation. Historically dominated by rigid optical assemblies and expensive reusable fiber-optic systems subject to severe cross-contamination risks, modern clinical practice increasingly demands high-definition digital visualization combined with single-use sterile safety architectures. As healthcare networks, Ambulatory Surgical Centers (ASCs), and intensive care units worldwide aggressively mitigate Healthcare-Associated Infections (HAIs), OEM/ODM manufacturing partners have become central to driving hardware innovation and cost containment.

China's medical electronics sector has evolved into the definitive hub for advanced endoscopic engineering. By combining ultra-compact CMOS chip-on-tip technology with high-efficiency optical lens moulding and automated micro-soldering pipelines, leading original equipment manufacturers provide global medical brands with scalable, regulatory-compliant manufacturing infrastructures. This shift is not merely about production cost reduction; it represents a comprehensive engineering integration of digital signal processing, ergonomic biomechanics, and ISO 10993 biocompatibility compliance.

Key Market Growth Driver: The global shift toward single-use flexible bronchoscopes, disposable video laryngoscopes, and single-use digital cystoscopes is projected to expand at a CAGR of over 14.5%. OEM partnerships allow regional healthcare brands to launch certified clinical devices with drastically reduced time-to-market and minimized capital expenditure.

End-to-End OEM/ODM Manufacturing Capabilities

From custom optical chip integration to biocompatible housing injection—tailored white-label engineering for global medical device brands.

As an established medical endoscope manufacturer and contract OEM provider, our industrial architecture covers the complete medical product lifecycle. OEM/ODM customization is structured across five vital core engineering disciplines:

1. CMOS & Optical Assembly

Micro-lens system design integration with ultra-low light CMOS camera sensors (resolutions up to 1080p Full HD / 4K signal pipelines), custom depth of field (3mm to 100mm), and field of view (FOV up to 120°).

2. Ergonomic Tool & Blade Design

Precision tooling for reusable titanium alloy/stainless steel handles, hyper-angulated video laryngoscope blades (Macintosh & Miller geometry), and medical-grade ABS/PC disposable insertion tubes.

3. Signal Processing & Firmware

Proprietary ISP (Image Signal Processor) software tuning featuring dynamic white balance, anti-fog illumination controls, edge enhancement algorithms, and customizable UI branding for clinical monitors.

Specification / Engineering Parameter Standard Production Capability OEM/ODM Customization Range
Image Sensor Technology 1/10" & 1/18" Medical CMOS Custom sensor tuning, High-Dynamic Range (HDR)
Outer Diameter (Insertion Tube) 2.8mm, 3.8mm, 5.2mm, 5.8mm 2.0mm ultra-thin to 6.4mm multi-channel
Articulation Steering Angle Up 180° / Down 130° (2-Way/4-Way) Custom tension & articulation lock mechanisms
Illumination System Integrated Tip LEDs (> 1500 Lux) Dual Light Fiber optic connection or UV/NBI modules
Water Resistance & Cleaning IPX8 Fully Submersible Integrity Autoclave-compatible, Steris, or Gas Sterilization

Who We Are: Haiye Medical Enterprise Profile

Leading Chinese Medical Endoscope Manufacturer with over a decade of innovative R&D, certified quality standards, and global distribution reach.

Haiye Medical was established in 2013, specializing in the field of medical endoscopy. We focus on the professional development and production of endoscopy devices, including a comprehensive range of clinical visual solutions such as video laryngoscopes, fiber optic laryngoscopes, video stylets, flexible video endoscopes, bronchoscopes, image processors, endoscope camera systems, and cold light sources.

Haiye is committed to creating higher quality products with advanced production technology. Haiye Medical has obtained international quality certifications such as CE, FDA, ISO9001, and ISO13485, ensuring rigorous quality standards throughout the entire production process to guarantee stable, reliable, and clinically safe performance.

As a premier medical endoscope company based in China, Haiye leverages over a decade of domain expertise. We pride ourselves on an integrated approach encompassing research and development, optical design, manufacturing, global sales, and responsive technical service. Today, our high-performance endoscopy equipment is trusted by clinical healthcare professionals in over 40 countries worldwide.

Our Milestones & Growth History

2013
Haiye Medical was established in Huyi District, Xi'an, initiating core optic engineering R&D.
2014
Successfully obtained official Class II Medical Device Manufacturing License.
2017
Dedicated international sales and technical support headquarters set up in Xi'an downtown.
2018
Expanded global exposure by exhibiting key product suites at MEDICA Fair in Dusseldorf, Germany.
2019
Established advanced micro-electronics operational subsidiary branch in Shenzhen.
2021
Headquarters office upgraded at Taihuabei Road, Xi'an; expanded global marketing facility.
2023
Acquired a modern new manufacturing plant to scale high-volume automated production.

Localization Support, Regulatory Compliance & Export Certification

Navigating medical device clearance across different geographic markets requires flawless documentation and strict adherence to international quality management systems. Haiye Medical provides full turnkey support for brand owners, importers, and regional distributors to accelerate local regulatory approvals:

  • ISO 13485:2016 Certification: Comprehensive Quality Management System governing design, micro-assembly, packaging, and risk management (ISO 14971).
  • CE MDR & US FDA 510(k) Readiness: Technical files, biocompatibility testing (ISO 10993-1, -5, -10), EMC/electrical safety test reports (IEC 60601-1, IEC 60601-1-2) tailored for fast local submission.
  • Localized Documentation & IFU: Multilingual Instructions for Use (IFU), packaging design customization, software GUI translation, and regional power/video connectivity configurations.

China Supply Chain Advantages

Our operational presence in Xi'an and Shenzhen unlocks unique supply chain efficiencies:

  • Integrated Industrial Hubs: Rapid prototyping of optical modules, PCBAs, and silicone molding within days.
  • Cost Efficiency: Reduced bill-of-materials (BOM) cost without compromising optical clarity or clinical safety.
  • Resilient Logistics: Robust global freight partnerships ensuring timely delivery under DDP/FOB terms.

Welcome To Our Factory & Manufacturing Center

We possess independent design and development capabilities while maintaining rigorous control over product cost, optical precision, and quality assurance.

Localized Clinical Application Scenarios

Engineered for versatile adoption across diverse clinical environments and emergency medical interventions.

Anesthesia & Airway Management

Facilitating routine and difficult endotracheal intubation in operating rooms. Hyper-angulated blades enable visualization of vocal cords in restricted airway scenarios without force application.

ICU & Emergency Resuscitation

Rapid deployment portable monitors allow critical care personnel to perform immediate bedside intubation, bronchial suctioning, and diagnostic assessment during respiratory failure.

Pulmonology & Bronchoscopy

Single-use flexible digital bronchoscopes eliminate re-processing costs and cross-contamination risks while providing crisp visualization for biopsy, lavage, and tracheal stenting.

Urology & Outpatient Procedures

Single-use digital flexible cystoscopes offer patient-friendly low-diameter insertion for diagnostic cystoscopy and stent removal in outpatient clinics.

ENT & Nasopharyngoscopy

Slim flexible nasopharyngoscopes for detailed examination of nasal passages, pharynx, and larynx, enhancing diagnostic precision in ENT consultations.

Veterinary Minimally Invasive Surgery

Specialized single-use and reusable veterinary endoscopy systems providing high-performance diagnostic visualization for small and large animal care.

Honor Certificates & Quality Approvals

Strict adherence to global quality and safety standards ensuring reliable performance in critical clinical settings.

Future Trends in Medical Endoscopy Manufacturing

Key technology vectors shaping the next decade of clinical visualization and surgical optics.

1. AI-Assisted Computer Vision

Integration of real-time AI algorithms directly into image processors for automated mucosal lesion recognition, vocal cord segmentation, and real-time anatomical orientation.

2. Micro-CMOS Chip Integration

Continued downsizing of image sensors below 1.0mm diameter, allowing ultra-thin flexible scopes to access peripheral bronchial sub-segments and pediatric lumens.

3. Eco-Friendly Single-Use Polymers

Transition to bio-recyclable medical polymers and modular sensor separation systems to minimize environmental impact while upholding sterile single-use standards.

Frequently Asked Questions (Q&A)

Crucial procurement, engineering, and compliance inquiries for OEM/ODM buyers and medical device exporters.

Q: What is the typical lead time for custom OEM endoscope manufacturing?
A: For standard white-label branding (logo placement, customized packaging, and localized IFU), lead times are typically 2 to 4 weeks. For complete ODM custom optical or mechanical handle tooling, prototype development requires 45 to 60 days, followed by regulatory sample verification.
Q: How do single-use flexible bronchoscopes compare in TCO to reusable scopes?
A: Single-use bronchoscopes eliminate costly STERIS/autoclave reprocessing equipment, manual labor, repair bills from handling damage, and cross-contamination liability. Over a 3-year operational window, single-use models reduce Total Cost of Ownership (TCO) by 25% to 40% per procedure.
Q: Do you assist OEM partners with local FDA 510(k) or CE MDR registration?
A: Yes, Haiye Medical provides comprehensive regulatory support dossiers, including IEC 60601-1 testing, ISO 10993 biocompatibility data, dynamic risk analysis (ISO 14971), and technical construction files required by notified bodies.
Q: What cleanroom standards are maintained in your production factory?
A: Our optics integration, lens assembly, and primary sterile packaging are performed in validated Class 100,000 (ISO Class 8) cleanroom environments certified under ISO 13485 quality protocols.

Complete Product Catalog & Systems

Explore our extended series of endoscopic image processors, reusable laryngoscopes, and single-use flexible instruments.

Disposable Flexible Nasopharyngoscope
Disposable Flexible Nasopharyngoscope
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Disposable Video Laryngoscope HYHJKM Series
Disposable Video Laryngoscope HYHJKM Series China Factory Suppliers
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HY-SCSTX1 Endoscopic Image Processor
HY-SCSTX1 Endoscopic Image Processor China Suppliers and Factory
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HD3b Endoscope Image Processor
HD3b Endoscope Image Processor
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HP-W/Z Reusable Laryngoscope
HP-W/Z Reusable Laryngoscope
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SingleUse Digital Flexible Cystoscope
SingleUse Digital Flexible Cystoscope Suppliers in China | HAIYE Medical Factory
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HYHJ-1330 Series Disposable Video Laryngoscope
HYHJ-1330 Series Disposable Video Laryngoscope
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High Performance HD3B Medical Image Processor
High Performance HD3B Medical Image Processor from China Factory Suppliers
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