Haiye Medical Haiye Medical
Whitepaper & Manufacturing Intelligence

OEM/ODM Portable Bronchoscopy Factories & Global Industrial Solutions

Next-Generation CMOS Video Bronchoscopes, Disposable Endoscopic Innovations, and ISO 13485 Manufacturing Ecosystems

Medical Tech Showcase

Primary Endoscopic Systems & Airway Platforms (Batch A)

Explore our core medical-grade endoscopy solutions, meticulously engineered for critical care, pulmonology diagnostics, and emergency airway intervention.

Reusable Flexible Nasopharyngoscope

Reusable Flexible Nasopharyngoscope

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HY-SCSTX1 Endoscopic Image Processor

HY-SCSTX1 Endoscopic Image Processor China Suppliers and Factory

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Disposable Video Laryngoscope HYHJKM Series

Disposable Video Laryngoscope HYHJKM Series China Factory Suppliers

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HYYZQ SingleUse Digital Flexible Bronchoscope

HYYZQ SingleUse Digital Flexible Bronchoscope China Factory and Suppliers

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Disposable Video Laryngoscope HYHJKP Series

Disposable Video Laryngoscope HYHJKP Series China Suppliers and Factory

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SingleUse Digital Flexible Nasopharyngoscope

SingleUse Digital Flexible Nasopharyngoscope China Suppliers and Factory

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SingleUse Digital Flexible Cystoscope

SingleUse Digital Flexible Cystoscope Suppliers in China | HAIYE Medical Factory

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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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Who We Are

Pioneering OEM/ODM Bronchoscopy Portable Factories

Established in 2013, Haiye Medical has emerged as a globally recognized manufacturer and R&D innovator specializing in advanced medical endoscopy systems. Headquartered in Xi'an with high-tech manufacturing expansion hubs in Shenzhen, Haiye Medical integrates end-to-end design, precision engineering, cleanroom assembly, and global regulatory compliance.

Our core product matrix encompasses portable video bronchoscopes, single-use digital flexible bronchoscopes, video laryngoscopes, fiber optic laryngoscopes, video stylets, disposable ureteroscopes, integrated medical image processors, and cold light source modules. By leveraging cutting-edge CMOS optical sensing and high-efficiency LED illumination, we provide clinical solutions trusted across 40+ countries.

Quality Assurance & Global Accreditations: Operating under rigorous quality management frameworks, Haiye Medical holds full certifications including CE Mark, US FDA, ISO 9001, and ISO 13485, guaranteeing uncompromised consistency, biocompatibility, and operational reliability for our international OEM/ODM procurement partners.

Decade of Excellence

Our Historical Growth & R&D Evolution

2013

Foundation: Haiye Medical was officially established in Huyi District, Xi'an, establishing dedicated optical and electronic endoscopy cleanroom facilities.

2014

Regulatory Licensing: Secured official Class II Medical Device Manufacturing Licenses, initiating mass production of anesthesia and airway endoscopes.

2017

Commercial Expansion: Downtown Xi'an global sales and market expansion center launched, strengthening international OEM/ODM partnerships.

2018

Global Recognition: World debut of portable video bronchoscopy systems at MEDICA in Düsseldorf, Germany, expanding distribution across Europe and Latin America.

2019

R&D Infrastructure Growth: Strategic expansion with a new subsidiary established in Shenzhen, focusing on advanced CMOS optical chips and AI image processing algorithms.

2021

Headquarters Modernization: Comprehensive renovation of the Xi'an headquarters at Taihuabei Road, establishing modern corporate sales, marketing, and technical support wings.

2023

Industry 4.0 Scaling: Acquisition of a high-capacity manufacturing plant to expand cleanroom production lines for single-use digital flexible bronchoscopes and endoscopic processors.

Engineering & Technology Architecture

Portable Bronchoscopy System Technical Ecosystem

Modern clinical environments require portable bronchoscopes to deliver high-definition visual fidelity, effortless deflection control, versatile working channels, and absolute sterility. As a specialized OEM/ODM factory, Haiye Medical engineers portable bronchoscopy platforms around four key technical pillars:

Advanced Optoelectronic Imaging

Integrating micro-CMOS sensors at the distal tip coupled with high-efficiency fiber-optic or chip-on-tip LED illumination. Provides 1080p Full HD dynamic resolution, auto-exposure tuning, and enhanced tissue structure recognition.

Precision Articulation Mechanics

Featuring ultra-flexible bending sections offering up to 210° Up / 130° Down articulation. Engineered with high-tensile stainless steel control wires for zero-backlash control and smooth anatomical navigation.

Multi-Functional Working Channel

Optimized inner diameter (1.2mm to 2.8mm) smooth polytetrafluoroethylene (PTFE) insertion tubes, permitting simultaneous suction, bronchoalveolar lavage (BAL), biopsy forcep deployment, and drug delivery.

Standard OEM/ODM Portable Bronchoscope Specification Matrix

The following benchmark parameters represent configurable options for our OEM/ODM client projects:

Parameter Category Standard Diagnostic Bronchoscope Therapeutic / ICU Bronchoscope Ultra-Slim Pediatric Bronchoscope
Distal Tip Outer Diameter 4.8 mm – 5.2 mm 5.8 mm – 6.2 mm 2.8 mm – 3.2 mm
Working Channel Inner Dia. 2.0 mm – 2.2 mm 2.8 mm – 3.0 mm 1.2 mm (Suction only)
Bending Range (Articulation) Up 180° / Down 130° Up 210° / Down 130° Up 160° / Down 130°
Field of View (FOV) 120° Wide Angle 120° Wide Angle 90° - 110°
Depth of Field (DOF) 3 - 50 mm 3 - 50 mm 2 - 30 mm
Image Signal / Connectivity Digital USB / HDMI / Wireless 5G Digital USB / HDMI / DisplayPort Direct-to-Monitor Digital Sync
Sterilization Compatibility Single-Use ETO / Gamma / Reusable Steris Single-Use ETO / Plasma Sterilization Single-Use ETO Sealed Packaging
Industrial Capability

China Industry 4.0: Supply Chain Resilience & Cost Advantage

Navigating the complex global medical device market requires a balance between strict quality control and cost efficiency. Operating from China’s leading medical device innovation clusters, Haiye Medical provides global OEM/ODM clients with strategic operational resilience.

10+
Years R&D Mastery
40+
Countries Exported
100k
Class Cleanrooms
100%
ISO 13485 Compliance

Vertical Integration & Component Sourcing

Our manufacturing ecosystem integrates precision micro-machining, automated SMT board placement, optical lens alignment, and leak testing within automated ISO Class 7 and Class 8 cleanrooms. By sourcing raw materials through consolidated domestic biomedical clusters, we mitigate international supply disruption while cutting BOM (Bill of Materials) costs by up to 35-45%.

Scalable Cleanroom Production Capacity

With our 2023 factory expansion, Haiye Medical boasts scalable assembly lines capable of delivering high-volume single-use flexible bronchoscopes and video laryngoscopes. Our automated testing rigs conduct 100% video signal calibration, insertion tube durability checks, and pressure decay leak tests before sterilization packaging.

OEM/ODM Partnership Framework

Tailored Customization Services for Global Enterprise Buyers

Whether you are an established medical equipment brand seeking private-label manufacturing or a healthcare innovator designing a bespoke bronchoscopy concept, Haiye Medical provides agile OEM/ODM workflows:

1. Private Labeling & Branding

Custom logo engraving on insertion handles, custom color-coding for different scope diameters, personalized packaging design, IFUs (Instructions for Use), and localized branded software startup screens.

2. Hardware & Mechanical Customization

Modifiable working channel dimensions, customized insertion tube lengths (e.g., 600mm to 1000mm), tailored bending torque, and custom connector interfaces (USB-C, HDMI, proprietary multi-pin lock).

3. Software & Image Processor Fine-Tuning

Custom digital signal processing (DSP) parameters, specialized white-balance profiles, multi-language UI localization, custom video outputs, and DICOM 3.0 hospital network integration.

R&D Vision

Technology Roadmap: Next-Gen Bronchoscopy Innovation

The landscape of pulmonology and critical care endoscopy is evolving rapidly. Haiye Medical’s dedicated R&D division in Shenzhen is actively advancing the following technological breakthroughs:

AI-Assisted Lesion Recognition & Depth Mapping

By integrating deep learning computer vision models directly into our next-gen image processors, our future bronchoscopy systems will offer real-time highlight overlays for suspicious mucosal dysplasia, early-stage tumors, and bleeding sites, providing clinicians with instant intraoperative diagnostic support.

Single-Use Ultra-Miniaturized Scopes (< 2.0mm OD)

Overcoming physical limits by adopting ultra-compact sub-millimeter CMOS optical sensors. These micro-bronchoscopes allow seamless navigation into peripheral distal bronchi and peripheral lung parenchyma, transforming bronchoscopic biopsy capabilities.

Low-Latency Wireless High-Definition Streaming

Utilizing ultra-wideband 6GHz wireless transmission modules to stream zero-latency 1080p video directly from the scope handle to ceiling-mounted ICU surgical monitors or portable handheld tablet displays, eliminating cumbersome cabling in crowded emergency suites.

Eco-Friendly Bio-Based Polymer Single-Use Scopes

Addressing global environmental standards by transitioning disposable bronchoscope handle casings to recyclable, medical-grade bio-polymers without sacrificing mechanical rigidity or tactile ergonomics.

Clinical Applications

Macro Industry Clinical Solutions & Hospital Workflows

Haiye Medical’s portable bronchoscopy portfolio caters to specialized medical workflows across diverse care environments:

ICU & Critical Care Bedside Airway Management

Portable video bronchoscopes allow immediate bedside inspection, sputum suctioning, atelectasis resolution, and double-lumen tube positioning in intensive care units without requiring heavy, stationary endoscopy carts.

Emergency Intubation & Pre-Hospital EMS

Compact, battery-operated designs combined with high-contrast displays empower emergency responders and anesthesiologists to navigate difficult airways, cervical spine injuries, and anatomical trauma reliably.

Outpatient Pulmonology Diagnostics & BAL

Single-use flexible digital bronchoscopes reduce cross-contamination risk, eliminate complex reprocessing cycles, and accelerate patient turnaround times in high-volume pulmonary diagnostic suites.

Regulatory Rigor

Global Regulatory Compliance & Safety Assurance

Entering global markets demands strict adherence to international medical device regulations. Haiye Medical provides complete technical documentation (Technical Files, STED) and quality management guarantees to support our OEM/ODM partners' local registration requirements:

ISO 13485 & Quality Management Systems

Our manufacturing infrastructure operates under audited ISO 13485 quality systems. Every stage—from component inspection (IQC), in-process quality control (IPQC), to final release (OQC)—is fully traceable under strict lot-tracking protocols.

CE MDR & US FDA 510(k) Readiness

Our products meet European CE Medical Device Regulations (MDR) and US FDA safety mandates. We perform comprehensive Cytotoxicity, Sensitization, Intracutaneous Reactivity, and Systemic Toxicity testing according to ISO 10993 biocompatibility standards.

Production Center

Manufacturing Facility & Production Equipment Showcase

Inside our state-of-the-art production base: showcasing specialized cleanrooms, precision assembly stations, testing rigs, and optical alignment apparatus:

Authorized Accreditations

International Certificates & Technical Documentation

Our international honor certificates validate our commitment to global safety compliance, sterile reliability, and manufacturing excellence:

Procurement Intelligence

Frequently Asked Questions (OEM/ODM Procurement FAQ)

Technical and commercial answers for medical device distributors, brand owners, and hospital procurement directors:

Q1: What are the Minimum Order Quantities (MOQ) for custom OEM/ODM bronchoscope projects?
For standard private-label customization (branded handles, custom logo printing, packaging), our MOQ starts at 50 units. For complete engineering modifications (custom distal tip tooling or custom PCB processor integration), MOQ typically starts at 200 units, supported by modular NRE (Non-Recurring Engineering) options.
Q2: How does Haiye Medical guarantee sterile integrity for single-use flexible bronchoscopes?
Our single-use bronchoscopes are manufactured in ISO Class 7/8 cleanrooms, individually vacuum-sealed in medical-grade tyvek pouches, and processed via validated Ethylene Oxide (ETO) or Gamma Ray sterilization cycles meeting ISO 11135 / ISO 11137 standards. Every batch includes bio-indicator sterility release certificates.
Q3: Can your portable bronchoscopes connect directly to hospital monitors or PACS systems?
Yes. Our portable processors feature HDMI, USB 3.0, and DVI digital video outputs. Furthermore, our HD3B and HY-SCSTX1 image processors support DICOM 3.0 network protocol integration for seamless archival to hospital Picture Archiving and Communication Systems (PACS).
Q4: What is the typical turn-around time for OEM prototype development?
For standard handle casing or software UI customization, working prototypes are ready within 15-20 business days. For advanced optoelectronic redesigns requiring new mold tooling, prototype sampling requires approximately 45-60 days including initial mechanical and optical testing.
Q5: What deflection mechanisms are used in your flexible bronchoscope range?
We employ proprietary high-tensile stainless wire systems coupled with micro-ratchet or friction-lock mechanisms. This setup ensures zero backlash, high mechanical durability over 10,000+ bending cycles, and ergonomic thumb control for precise articulation up to 210°.
Q6: Do you offer technical training and spare parts support for international distributors?
Yes, we provide comprehensive technical service manuals, component-level schematic documentation, online engineer training, and guaranteed spare parts availability (optics modules, articulation wires, mainboard PCBA) for a minimum of 7 years post-discontinuation.
Expanded Product Lines

Specialized Single-Use & Multi-Specialty Endoscopes (Batch B)

Explore our extended series of video laryngoscopes, single-use digital ureteroscopes, and veterinary image processing platforms:

Disposable Flexible Ureteroscope

Disposable Flexible Ureteroscope

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SingleUse Digital Flexible Ureteroscope HYYM2.8AB

SingleUse Digital Flexible Ureteroscope HYYM2.8AB China Suppliers Factory

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HYHJ-1320 Disposable Video Laryngoscope

HYHJ-1320 Disposable Video Laryngoscope

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Veterinary Endoscope Image Processor

Veterinary Endoscope Image Processor

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HYHJ-KM Series Disposable Video Laryngoscope

HYHJ-KM Series Disposable Video Laryngoscope

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HP-Y Disposable Laryngoscope

HP-Y Disposable Laryngoscope

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HYYBYH Digital Flexible Nasopharyngoscope

HYYBYH SingleUse Digital Flexible Nasopharyngoscope China Factory and Suppliers

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SingleUse Digital Flexible Bronchoscope HYYZQ Series

SingleUse Digital Flexible Bronchoscope China Suppliers and Factory HYYZQ Series

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