Haiye Medical Haiye Medical

Custom OEM Endoscope Company Manufacturer & Exporter

Pioneering Next-Generation Single-Use & Flexible Endoscopy Systems for Global Medical & Industrial Healthcare Partners with Advanced Optical Engineering.

Featured Endoscopic Innovations

High-Precision Endoscopy Systems & Single-Use Instruments

Explore our flagship OEM endoscopy solutions engineered for critical airway management, ENT diagnostics, urology procedures, and medical imaging signal processing.

Disposable Flexible Bronchoscope

Disposable Flexible Bronchoscope

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SingleUse Digital Flexible Nasopharyngoscope

SingleUse Digital Flexible Nasopharyngoscope China Suppliers and Factory

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HYHJ-KM Series Disposable Video Laryngoscope

HYHJ-KM Series Disposable Video Laryngoscope

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Disposable Veterinary Endoscope

Disposable Veterinary Endoscope

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HAIYE HD3B Image Processor Medical Endoscopy System

HAIYE HD3B Image Processor Medical Endoscopy System China Suppliers Factory

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HYYBYH SingleUse Digital Flexible Nasopharyngoscope

HYYBYH SingleUse Digital Flexible Nasopharyngoscope China Factory and Suppliers

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HY-SCSTX1 Endoscopic Image Processor

HY-SCSTX1 Endoscopic Image Processor China Suppliers and Factory

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Electronic Nasopharyngoscope BYH Series

Electronic Nasopharyngoscope BYH Series China Factory Suppliers

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Macro Industry Insight

The Strategic Paradigm Shift in Global Minimally Invasive Endoscopy

Analyzing the technological evolution from traditional reusable optics to single-use CMOS micro-imaging platforms in modern clinical workflow.

The global medical endoscopy market is undergoing an unprecedented structural transformation. Historically dominated by rigid and complex reusable fiber-optic architectures, clinical practices across anesthesia, pulmonology, urology, and otolaryngology (ENT) are rapidly pivoting toward high-definition single-use flexible video endoscopes. Driven by stringent healthcare-associated infection (HAI) mitigation protocols, zero cross-contamination mandates, and the rising total cost of ownership (TCO) associated with complex reprocessing, medical device distributors and hospital procurement committees are actively prioritizing agile single-use platforms.

As a specialized Custom OEM endoscope company manufacturer & exporter, Haiye Medical bridges the gap between state-of-the-art optoelectronic engineering and scalable medical device manufacturing. By integrating sub-millimeter CMOS-on-Tip sensors, multi-spectrum LED illumination micro-engines, and ergonomically tailored insertion tubes, we empower medical device brands worldwide to deliver clinical excellence with optimized marginal production costs.

Information Gain Insight: Modern clinical economics reveal that reprocessing a reusable endoscope—including enzymatic washing, high-level disinfection (HLD), automated endoscope reprocessor (AER) maintenance, and microbiological auditing—incurs an average indirect cost of $140 to $280 per procedure. Single-use digital flexible video endoscopes eliminate reprocessing turn-around time, completely eradicate cross-infection risks, and provide guaranteed diagnostic image sharpness for every procedure.
40+
Global Export Markets
10+
Years R&D Expertise
100k
Cleanroom Grade Facility
100%
ISO 13485 & CE Compliance
Corporate Profile

WHO WE ARE: Haiye Medical OEM/ODM Leadership

Integrating end-to-end R&D, precision molding, optical integration, and international quality management systems.

Founded & Established

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

Rigorous Certification Standards

Haiye is committed to creating higher quality products with advanced production technology. Haiye Medical has obtained certifications such as CE, FDA, ISO9001, and ISO13485, ensuring the implementation of strict quality standards throughout the production process to guarantee stable and reliable product quality.

Global OEM & ODM Supply Chain

Haiye is a leading medical endoscope company and manufacturer based in China. With over a decade of expertise in video endoscope technology, we pride ourselves on a comprehensive approach to R&D, production, sales, and service. Our high-quality endoscopy equipment is trusted by professionals in over 40 countries worldwide.

Our Strategic Development Milestone Timeline

2013
Haiye was established in Huyi District, Xi'an, initiating core optical R&D.
2014
Obtained official medical device manufacturing license in China.
2017
Dedicated international sales and marketing team was set up in Xi'an downtown.
2018
Attended MEDICA fair in Düsseldorf, Germany, expanding global OEM partnerships.
2019
Haiye's subsidiary technology company was established in Shenzhen for advanced R&D.
2021
Renovated HQ offices at Taihuabei Road, Xi'an; expanded global marketing operations.
2023
Acquired a modern new manufacturing plant, preparing for large-scale production expansion.
Technical Engineering Architecture

Turnkey OEM/ODM Engineering Specifications & Capabilities

Delivering custom medical-grade optoelectronic solutions tailored to client specification, regulatory compliance, and market demands.

Micro CMOS Sensor & Lens Integration

We specialize in packaging ultra-compact CMOS sensors (down to 1/18" and 1/15" formats) paired with multi-layer glass optical lenses. Our micro-optics achieve up to 1080p Full HD resolution, 120° wide angle depth of field, and customized anti-fogging lens coatings.

Distal Tip Articulation Mechanics

Precision control wire tensioning systems allow bi-directional or 4-way articulation (Up 180°, Down 130°). Designed with high torsional stiffness and biocompatible polyether block amide (PEBAX) jacket extrusion for ultra-smooth insertion.

Signal Processing & ISP Algorithms

Our proprietary Image Signal Processors (e.g., HD3B, HY-SCSTX1, HY-TS13) feature custom FPGA/DSP pipelines providing automated gain control, dynamic edge sharpening, noise reduction, and white balance calibration optimized for tissue contrast.

OEM/ODM Customization Workflow Pipeline

1. Requirement Freeze

Optical specs, outer diameter (OD), working channel dimensions, interface type.

2. Rapid Prototyping

3D CAD layout, micro-optical ray tracing, rapid tooling, and ISP software adaptation.

3. Verification & Testing

Biocompatibility testing, mechanical fatigue, ingress protection (IPX7/IPX8), electrical safety.

4. Regulatory Dossiers

FDA 510(k) technical file submission support, CE MDR documentation, ISO 13485 audit trail.

5. Mass Production

Class 100,000 cleanroom assembly, automated optical alignment, ethylene oxide (EO) sterilization.

Clinical Applicability

Localized Application Scenarios Across Medical Speciality Disciplines

Tailored visualization technology serving diverse clinical workflows from critical emergency care to specialized veterinary medicine.

Anesthesia & Difficult Airway Management

In ICU intubation and emergency airway rescue, Haiye video laryngoscopes (HYHJ-KM series, HYHJ-KC reusable series, HYHJ-1330 disposable series) provide high-resolution real-time glottic visualization. Designed with hyperangulated blades, integrated high-power LEDs, and anti-fogging distal heaters, clinicians can achieve successful first-pass endotracheal intubation in challenging anatomical conditions.

Pulmonology & Interventional Bronchoscopy

Our single-use digital flexible bronchoscopes enable quick bed-side bronchoalveolar lavage (BAL), endotracheal aspiration, and biopsy procedures. Eliminating cross-contamination between immunocompromised patients in intensive care units, these flexible bronchoscopes offer dual-deflection control and tight bending radii for deep segmental bronchial navigation.

Urology Outpatient & Diagnostic Cystoscopy

The single-use digital flexible cystoscope series offers pain-free urethral insertion due to smooth hydrophilic coating and ultra-thin outer sheath diameters. Equipped with dedicated working channels for stone retrieval baskets and biopsy forceps, urologists benefit from crystal-clear lower urinary tract visualization without capital disinfection burden.

ENT Diagnostic Nasopharyngoscopy

Providing delicate, minimal-diameter diagnostic scope options (BYH series digital flexible nasopharyngoscopes), outpatient ENT specialists can effortlessly evaluate nasal passages, pharyngeal soft tissue, and vocal cord mobility with minimal patient discomfort and instant video recording interface.

Veterinary Minimally Invasive Surgery

Designed for small companion animals and exotic species, our veterinary endoscopes allow small animal clinics to perform gastrointestinal foreign body retrieval, tracheoscopy, and otoscopy with high resolution, durable sheathing, and portable image processors.

Image Processing & Integrated Operating Rooms

Standalone endoscopic image processors (HD3B, HY-SCSTX1, HY-TS13) act as the central optical brain, featuring HDMI/DVI/USB live streaming video output for easy integration into cart-based medical trolleys and hospital PACS networks.

Factory Showcase

Welcome To Our Manufacturing Plant & Facilities

We not only have independent design and development capabilities, but strictly control product cost and quality across every assembly step.

direct laryngoscope price facility
direct laryngoscopy video testing line
electronic laryngoscope assembly cleanroom
fiber optic video laryngoscope workshop
flexible laryngoscopy video quality check
flexible video laryngoscope manufacturing
glide laryngoscope optical inspection
haiye video laryngoscope precision line
handheld video laryngoscope testing room
hyperangulated video laryngoscope production cleanroom
Quality Assurance

CERTIFICATE: Our International Honor Certificates & Approvals

Certified for worldwide distribution under stringent global regulatory frameworks.

intubating laryngoscope CE certification
intubation with video laryngoscope ISO 13485 certification
laryngoscope company FDA registration
laryngoscope cost ISO 9001 compliance
insighters video laryngoscope certificate honor
Future Horizon

Technology Roadmap & Next-Gen Endoscopy Outlook (2025–2030)

Driving technological convergence between artificial intelligence, ultra-miniaturized sensors, and eco-sustainable medical polymers.

Phase 1: 2025

4K Micro-CMOS Integration

Deployment of sub-1.0mm 4K resolution image sensors into single-use ureteroscopes and bronchoscopes, delivering unprecedented clarity for micro-lesion identification.

Phase 2: 2026

AI-Assisted CADe/CADx Algorithms

Embedding edge AI directly into image processors (HD3B series) for real-time mucosal abnormality detection, automatic vascular pattern enhancement, and lesion segmentation.

Phase 3: 2027–2028

Wireless Ultra-Low Latency Video Stream

Implementation of 60GHz millimeter-wave wireless video transmission protocol, decoupling handle mobility from physical monitor consoles in surgical suites.

Phase 4: 2029–2030

Eco-Friendly Bio-Polymer Recycling

Transitioning single-use insertion tube components to 100% recyclable, biodegradable medical-grade polymers without compromising torque stiffness or flexibility.

Technical & Commercial FAQ

Frequently Asked Questions (Q&A)

Clear, authoritative answers regarding OEM/ODM collaboration, regulatory support, product specifications, and ordering.

Q: What parameters can be customized under Haiye's OEM endoscope manufacturing program?
We offer total customization including insertion tube outer diameter (OD), working channel lumen size, optical field of view (FOV 90°-120°), depth of field (DOF), handle ergonomic styling, custom button configuration, cable lengths, logo laser marking, custom packaging/sterilization pouches, and custom Image Signal Processor (ISP) firmware.
Q: How does Haiye ensure quality compliance and regulatory authorization for export markets?
Haiye Medical operates under ISO 13485 and ISO 9001 quality management systems. Our primary single-use and reusable endoscope product lines hold CE marks (under EU MDR pathways) and US FDA clearances. We supply full technical dossiers, DHF (Design History File), and biocompatibility test reports (ISO 10993) to facilitate local product registration for our global distributors.
Q: What are the distinct clinical benefits of Single-Use Flexible Bronchoscopes over traditional scopes?
Single-use flexible bronchoscopes eliminate cross-contamination hazards, completely remove hospital decontamination costs, ensure 100% sterile availability for emergency bedside procedures (e.g., in ICU intubations), and eliminate scope repair downtime caused by working channel damage or optical fiber breakdown.
Q: What is the standard development lead time for a custom OEM/ODM video laryngoscope or endoscope project?
Standard OEM branding (custom color scheme, logo branding, box artwork) takes approximately 2 to 4 weeks. Full custom ODM engineering (new mechanical design, custom PCB layout, micro-optics packaging) typically ranges from 3 to 6 months from initial requirement freeze to pilot batch validation.
Q: Can your image processors (HD3B, HY-SCSTX1, HY-TS13) interface with existing hospital monitors?
Yes. Our image processors feature multi-format video output interface ports including HDMI, DVI, VGA, and USB 3.0 digital stream output, allowing plug-and-play connectivity with standard medical-grade displays, computers, surgical carts, and integrated operating room setups.
Q: What sterilization methods are validated for Haiye disposable flexible endoscopes?
Our single-use disposable endoscopes are packaged in sterile medical-grade Tyvek pouches and validated for Ethylene Oxide (EO) sterilization in compliance with ISO 11135 standards, providing a guaranteed shelf life of 2 to 3 years.
Q: Does Haiye support veterinary OEM medical devices?
Yes. We manufacture robust, specialized veterinary endoscopes (including disposable and semi-flexible models) engineered with specific shaft lengths and outer diameters optimized for small animal and equine diagnostic/therapeutic procedures.
Q: What is the Minimum Order Quantity (MOQ) for OEM orders?
We provide flexible MOQ thresholds depending on the product tier. For standard private-label OEM packaging, MOQs start as low as 50 to 100 units. For fully customized hardware ODM development, initial volume commitments are structured around tooling amortizations.
Complete Hardware Portfolio

Explore Additional Specialized Endoscopy Hardware

High-performance diagnostic processors, cystoscopes, and laryngoscopy equipment for full-spectrum hospital procurement.

High Performance HD3B Medical Image Processor

High Performance HD3B Medical Image Processor from China Factory Suppliers

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HYHJ-KC Reusable Video Laryngoscope

HYHJ-KC Reusable Video Laryngoscope

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SingleUse Digital Flexible Bronchoscope HYYZQ Series

SingleUse Digital Flexible Bronchoscope China Suppliers and Factory HYYZQ Series

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HY-TS13 Endoscope Image Processor

HY-TS13 Endoscope Image Processor

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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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Disposable Flexible Cystoscope

Disposable Flexible Cystoscope

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HD3b Endoscope Image Processor

HD3b Endoscope Image Processor

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