How long is the lead time?

The average lead time is one month for both peak and off-peak seasons.

What sizes are available?

Sizes range from 10Fr to 18Fr with various effective lengths.

Is the product sterilized?

Yes, it is sterilized using Ethylene Oxide.

Ureteral Access Sheath Ureter Smooth Hydrophilic Coating with CE ISO

Name: Ureteral Access Sheath Ureter Smooth Hydrophilic Coating with CE ISO
Brand: Haiyan Kangyuan Medical Instrument Co., Ltd.
SKU: 2011129945

Zhejiang, ChinaHaiyan Kangyuan Medical Instrument Co., Ltd.

Negotiable

1,000 Pieces

Sample price:US$0.00/piece.Request sample

Product profile

Customization

Available

Material

Plastic

Ethylene Oxide Sterilization

Model NO.

Ureteral Access Sheath

Quality Guarantee Period

5 Years

Group

All

Logo Printing

Negotiable

Usage

Hospital

Factory

Yes

Registration Documents

Available

Medical Classification

Class II

Single Use

Yes

Certification

CE, ISO13485, FDA

Transport Package

Packing: 5 PCS/Box, 20 PCS/Carton

Specification

10Fr-18Fr

Trademark

Madewell or OEM

Origin

Jiaxing Zhejiang China

HS Code

9018390000

Production Capacity

600000 PCS

Key features

Hydrophilic Coating: Ureteral access sheath features a smooth hydrophilic coating for enhanced performance.

Wide Size Range: Available in sizes 10Fr to 18Fr with multiple effective length options.

Multiple Certifications: Certified with CE, ISO 13485, and FDA standards for medical safety.

5-Year Warranty: Comes with a 5-year quality guarantee period for peace of mind.

Single Use Design: Designed for single use in hospital settings to ensure hygiene.

OEM/ODM Services: Full customization, minor customization, and design-based options available.

Ethylene Oxide Sterilized: Sterilized using Ethylene Oxide for immediate clinical readiness.

Class II Medical Device: Registered as a Class II medical device with all necessary documentation.

Company profile

Importers and ExportersHigh Repeat Buyers ChoiceYears of Export ExperienceProduct Certification

Haiyan Kangyuan Medical Instrument Co., Ltd.

Zhejiang, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc. CertifiedExport Year: 19 Years CertifiedNearest Port: Shanghai Port, Ningbo PortAverage Response Time: ≤9.46h

AI-Powered supplier vetting

SummaryThe supplier operates manufacturing facilities for molding, extrusion, and sterilization and is engaged in Class I medical-device and protective-equipment production. It supports extensive customization, ODM, and OEM services, with documented finished-product inspection instructions and stated quality assurance. Export experience is substantial, with 19 years of exporting and 71%–90% of sales from exports. However, the supplier reported no new products in the past year, no 3D software design, no ERP/OA/CRM/SAP digital integration, no inventory or overseas service infrastructure, and no valid manufacturing-capacity contract with related subcontractors. Corrective-action and complaint-handling procedures exist but lack written records. CE certification is stated, while management-system certification is listed only as “Others.”

Supplier typeThe supplier is a manufacturing-oriented enterprise with molding, extrusion, and sterilizing facilities, and its stated business scope includes production of Class I medical devices, masks, labor-protection equipment, and medical protective equipment. This indicates a direct manufacturer profile rather than a purely trading or service intermediary.

CertificationsThe supplier states that its products hold CE certification. Its management-system certification is recorded only as “Others,” without identifying a specific recognized standard, so the evidence supports product compliance certification but not a clearly verifiable management-system certification.

Production capacityProduction infrastructure includes molding, extrusion, and sterilizing facilities, with a one-month stated lead time in both peak and off-season periods and 19 years of export experience. However, the supplier has no in-stock capacity and no valid manufacturing-capacity contract with related subcontractors, so production capability is supported but includes operational limitations.

Customization capabilityThe supplier explicitly supports customization from samples, customization from designs, full customization, minor customization, and flexible customization, and also offers ODM and OEM services for popular brands. These statements directly evidence broad customization capability, although 3D software design is not provided.