Haiye Medical Haiye Medical
Precision Medical Engineering White Paper

OEM/ODM Endoscopy Device Manufacturers & Factories

Architecting Next-Generation Surgical Imaging Systems, Single-Use CMOS Endoscopes, and Advanced Image Processors for Global MedTech Leaders.

Product Catalog Part I

Featured OEM/ODM Endoscopy Solutions

High-performance digital flexible endoscopes, video laryngoscopes, and image processors manufactured to ISO13485 standards.

HYYBYH SingleUse Digital Flexible Nasopharyngoscope
HYYBYH SingleUse Digital Flexible Nasopharyngoscope China Factory and Suppliers
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Electronic Nasopharyngoscope BYH Series
Electronic Nasopharyngoscope BYH Series China Factory Suppliers
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Disposable Flexible Cystoscope
Disposable Flexible Cystoscope
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HY-SCSTX1 Endoscopic Image Processor
HY-SCSTX1 Endoscopic Image Processor China Suppliers and Factory
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Reusable Flexible Nasopharyngoscope
Reusable Flexible Nasopharyngoscope
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HYTS13 Endoscopic Image Processor
HYTS13 Endoscopic Image Processor High Definition Medical Factory Suppliers in China
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Disposable Flexible Bronchoscope
Disposable Flexible Bronchoscope
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HPWZ Reusable Fiber Optic Laryngoscope
HPWZ Reusable Fiber Optic Laryngoscope China Factory and Suppliers
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Industry Insight & Strategic Overview

The Paradigm Shift in Modern OEM/ODM Medical Endoscopy Manufacturing

Navigating the transition from traditional reusable optics to single-use CMOS micro-imaging platforms and AI-enabled edge hardware.

Global Market Dynamics

The global endoscopy market is accelerating toward ultra-definition micro-cameras and single-use modalities. Hospital networks prioritize cross-contamination risk elimination, driving double-digit annual growth for disposable flexible scopes across Pulmonology, Urology, and ENT specialties.

Chip-on-Tip Sensor Evolution

Modern ODM manufacturing leverages wafer-level optics and sub-millimeter CMOS sensor packages (1/10" and smaller). Integrating LED light guides and micro-lenses into flexible shafts requires ultra-precision cleanroom micro-assembly and dynamic ISP calibration.

Rigorous Regulatory Compliance

Procurement teams require comprehensive design master files (DMF), ISO 10993 biocompatibility verification, and seamless alignment with FDA 510(k) and EU MDR Annex IX requirements. Enterprise OEM engineering ensures zero-defect quality control across production batches.

10+ Years
Dedicated Endoscopy R&D Expertise
40+
Countries Exported & Supported Globally
ISO 13485
Certified Medical Quality Management
FDA & CE
Global Regulatory Compliance Ready
WHO WE ARE

Pioneering OEM/ODM Endoscopy Device Manufacturing

Combining cutting-edge optoelectronic engineering, vertically integrated manufacturing, and global service excellence.

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 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.

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 quality standards throughout the production process to guarantee stable and reliable product quality.

"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."

Haiye Medical Cleanroom Facility

Trusted Endoscopy Machine Supplier & OEM Solution Partner

Our high-quality endoscopy equipment is trusted by medical professionals in over 40 countries worldwide. As your trusted partner, Haiye video laryngoscope offers a wide range of cutting-edge endoscope manufacturing solutions, including anesthesia fiber optic laryngoscopes, reusable and disposable video laryngoscopes, flexible video laryngoscopes, electronic bronchoscopes, disposable ureteroscopes, multifunctional airway trolleys, medical image processors, and medical endoscopy camera systems.

  • Customized Mechanical & Ergonomic Handle Styling
  • Optoelectronic Signal Conditioning & Tailored Sensor Integration
  • Custom Software UI, ISP Fine-Tuning & Multi-Language Support
  • Turnkey Private Labeling, Packaging, and Global Registration Guidance
Advanced Digital Laryngoscope R&D

Our Growth Journey & History

2013
Haiye was established in Huyi District, Xi'an.
2014
Obtained medical device manufacturing license.
2017
Sales team set up in Xi'an downtown.
2018
Attended MEDICA fair in Düsseldorf, Germany.
2019
Secondary company established in Shenzhen.
2021
Office renovated at Taihuabei Road; Marketing dept. launched.
2023
Acquired new manufacturing plant for production expansion.
R&D Roadmap

Technological Innovations Driving Next-Gen Endoscopy

How our OEM/ODM R&D team solves complex engineering challenges across optoelectronics, edge computing, and material science.

Chip-on-Tip Micro CMOS Assembly

Eliminating cumbersome rod-lens trains, our micro-sensor packaging places high-resolution CMOS chips directly at the insertion tube apex. This yields exceptional 1080p and 4K optical clarity in scope diameters as small as 2.8mm, ideal for delicate ureteroscopy and pediatric pulmonology.

Smart ISP Algorithms & Narrow-Band Light

Our proprietary Image Signal Processors (ISP) perform real-time latency-free noise reduction, wide dynamic range (WDR) compensation, and mucosal vascular enhancement. Advanced spectral illumination highlights subtle capillary anomalies for early-stage lesion detection.

Ergonomic Mechanical Articulation

Precision-braided insertion tubes combined with micro-cable steering mechanisms offer 210° up/down bending angles. Lightweight handle designs minimize physician fatigue during extended operating room (OR) and ICU airway management procedures.

China Industry 4.0

Supply Chain Resilience & High-Precision Production Infrastructure

Why leading medical equipment brands partner with Haiye for turnkey OEM/ODM contract manufacturing.

Vertical Integration

From in-house precision mold tooling and micro-injection molding to SMT circuit board assembly and lens bonding, we control the complete manufacturing value chain to maintain stringent quality and aggressive lead times.

Cleanroom Standards

Device packaging and optical sheath assembly take place within controlled ISO Class 8 (Class 100,000) cleanrooms. Micro-lens bonding and optical calibration are conducted under laminar flow hoods to guarantee zero particle contamination.

Scalable Yield Efficiency

Equipped with high-volume automated test stations, leak testers, and optical bench testing gear, our facility seamlessly scales from low-volume custom prototyping to multi-thousand unit mass production runs.

Factory Overview

Welcome To Our Factory & Manufacturing Floor

We not only have independent design and development capabilities, but strictly control product cost and end-to-end quality.

GLOBAL CERTIFICATIONS

International Quality Standards & Accreditation

Rigorous regulatory adherence ensuring smooth commercial distribution across North America, Europe, Asia-Pacific, and LATAM.

Cooperation Framework

Tailored OEM & ODM Engagement Models

Flexible partnership structures designed for medical device brands, distributors, and healthcare systems.

01

Turnkey White-Label OEM

Select from our catalog of pre-certified video laryngoscopes, bronchoscopes, and image processors. We apply your custom branding, logo laser etching, localized UI software, custom outer packaging, and multilingual manuals.

02

Full-Custom ODM Development

Co-engineer proprietary endoscopic solutions from napkin sketch to mass production. Includes industrial design (ID), mechanical CAD modeling, PCB/schematic engineering, firmware coding, prototype tooling, and clinical testing support.

03

CKD / SKD Supply Options

For global medical OEMs seeking local assembly tariff benefits or regional manufacturing compliance, we supply Completely Knocked Down (CKD) or Semi-Knocked Down (SKD) sub-assemblies alongside comprehensive technical transfer.

TECHNICAL BUYER'S GUIDE

Frequently Asked Questions (FAQ)

Essential insights for procurement managers, medical engineers, and international distributors.

Q: What certifications do Haiye Medical endoscopy devices carry for international market access?
Haiye Medical operates strictly under an ISO 13485 and ISO 9001 certified quality management system. Our flagship endoscopy lines, including single-use and reusable video laryngoscopes and image processors, hold CE certificates under European MDR standards and US FDA clearance/registrations, enabling seamless compliance across global regulatory jurisdictions.
Q: What is the typical development timeline for custom ODM endoscopy projects?
A standard custom ODM project progresses through conceptual styling, optical engineering, rapid prototyping, tool building, and trial production. Initial functional prototypes are typically ready within 60 to 90 days. Regulatory verification testing, biocompatibility evaluation (ISO 10993), and pilot manufacturing runs generally take an additional 3 to 6 months depending on client specification complexity.
Q: How do single-use (disposable) flexible endoscopes compare to reusable scopes in total cost of ownership (TCO)?
Single-use endoscopes completely eliminate costly reprocessing equipment, manual enzymatic wash labor, sterilization chemistry consumables, and expensive repair bills associated with scope damage. For hospital departments handling high patient volumes or emergency interventions, disposable scopes lower cross-contamination risk and ensure predictable per-procedure accounting.
Q: What options are available for image processor customization (ISP & Hardware)?
Our engineering team provides end-to-end custom image processing solutions. We can adapt ISP algorithms for multi-band illumination, customized color spectrum profiling, algorithmic edge enhancement, picture-in-picture outputs (HDMI, SDI, USB3.0, Wi-Fi streaming), and bespoke user interface (UI) design with corporate branding and multi-language support.
Q: How does Haiye ensure raw material biocompatibility for flexible insertion shafts?
All patient-contact materials—including outer polymer jacketing, distal tip encapsulants, optical windows, and working channel liners—undergo rigorous ISO 10993 testing. This covers cytotoxicity, sensitization, intracutaneous reactivity, and systemic toxicity testing to guarantee patient safety during prolonged surgical and diagnostic procedures.
Q: What are the Minimum Order Quantities (MOQ) for OEM private labeling vs OEM custom engineering?
For standard catalog products requiring private labeling, custom logo branding, and localized packaging, MOQs are highly flexible, often starting at 20 to 50 units. For full ODM projects requiring custom tooling, specialized optical molds, or dedicated PCB redesigns, project-specific MOQs are established based on non-recurring engineering (NRE) investment models.
Product Catalog Part II

Advanced Imaging Processors & Speciality Endoscopes

Explore our full line of HD image processors, disposable laryngoscopes, and flexible video cysto/ureteroscopes.

HD3b Endoscope Image Processor
HD3b Endoscope Image Processor
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High Performance HD3B Medical Image Processor
High Performance HD3B Medical Image Processor from 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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HP-Y Disposable Laryngoscope
HP-Y Disposable Laryngoscope
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HY-TS13 Endoscope Image Processor
HY-TS13 Endoscope Image Processor
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HYHJ-KM Series Disposable Video Laryngoscope
HYHJ-KM Series Disposable Video Laryngoscope
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SingleUse Digital Flexible Ureteroscope HYYM2.8AB
SingleUse Digital Flexible Ureteroscope HYYM2.8AB China Suppliers Factory
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HY-TS13 Endoscopic Image Processor Medical Imaging
HY-TS13 Endoscopic Image Processor Medical Imaging Factory Suppliers in China
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