Hainwise Medical Technology Co.,Ltd
- E-mail: info@hainwise.com
Hainwise Medical Technology Co.,Ltd
Standard products cannot meet the requirements of all surgeries and equipment. Common problems in clinical practice include size mismatch, poor maneuverability, low compatibility, etc., which may affect the doctor's operating efficiency and surgical success rate.
Hainwise provides a one-stop customized solution to make the product more suitable for each customer's specific usage scenario.
As a manufacturer specializing in custom medical guidewires and catheters with over 16 years of R&D experience, Hainwise focuses exclusively on OEM & ODM development.
We support clients at every stage of the device lifecycle — from rapid prototyping to full-scale manufacturing. Our solutions cover a broad range of clinical applications, including:
Vascular Access
Urology
Gastroenterology
Peripheral Vascular
Cardiovascular
Neurovascular
We provide global medical brands, distributors, and clinical institutions with full-spectrum OEM/ODM services — from concept design and development to compliant manufacturing and delivery.
Each custom product is built to meet brand identity and regulatory entry requirements, helping clients expand into global markets faster and with confidence.
We offer extensive customization options tailored to your clinical, functional, and branding needs.
Length (e.g., 40–300cm)
Coating Type (Hydrophilic / PTFE)
Core Wire Stiffness
Tip Flexibility & Shape (Straight, J-tip)
Radiopaque Markers (number and position)
Outer Diameter (e.g., 0.018", 0.035")
Packaging Style (Single-use or bulk)
Diameter & Length (Fr/mm)
Material (PU / PE / PTFE)
Tip Design (closed tip, side holes)
Connector Type (Luer lock, custom fitting)
Radiopaque Marking Options
Color and Identification Marks
Label, IFU, and packaging tailored to your brand identity
Multi-language documentation, barcode/QR integration
OEM sterile packaging or neutral bulk packaging
Example: A Zebra guidewire can be custom-built with a hydrophilic tip and increased shaft stiffness for improved navigation in complex urinary procedures.
We follow a structured workflow to ensure technical feasibility, regulatory compliance, and clinical effectiveness:
Product Concept Consultation
Clarify your technical needs and market objectives.
Design & Risk Management
Provide full-process risk analysis and control documentation.
Sample Prototyping & Functional Testing
Complete prototyping and conduct design verification and validation.
Documentation & Regulatory Support
Provide full DHF documentation package and regulatory consulting.
Mass Production & Delivery
Manufacture under ISO 13485-certified system with batch traceability.
Post-Market Monitoring
Includes adverse event tracking, trend analysis, and vigilance reporting.
Whether you are looking to private-label our proven products or co-develop innovative guidewires and catheters with custom functionalities, Hainwise Medical offers flexible collaboration models to suit your needs.
OEM Services:
Branding existing guidewires and catheters with your logo, along with customized labeling and packaging.
ODM Services:
Complete development from concept to production — including structural design, material selection, prototyping, and volume manufacturing.
Our products are manufactured in ISO 13485:2016-certified facilities and fully aligned with global regulatory systems.
We ensure every customized product is traceable, verifiable, and supported with regulatory-ready documentation.
✅ ISO 13485:2016 Certified QMS
✅ FDA Establishment Registered + CFG (Certificate to Foreign Government)
✅ EU MDR 2017/745 documentation in progress
✅ Regulatory support files tailored for country-specific MOH submissions
Complaint reporting and escalation system
Adverse event investigation
Medical device vigilance system integration
Trend analysis and safety statistics
Periodic Safety Update Reports (PSURs)
Corrective and Preventive Actions (CAPA)
Contact our customization team today to discuss your product needs.
Email: info@hainwise.com
[Submit Customization Form]
