What is the lead time for production?

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

Is the product sterilized?

Yes, the product is sterilized using Ethylene Oxide.

Ureteral Access Sheath Ureter Smooth Hydrophilic Coating 10fr-18fr CE Certificate

Name: Ureteral Access Sheath Ureter Smooth Hydrophilic Coating 10fr-18fr CE Certificate
Brand: Haiyan Kangyuan Medical Instrument Co., Ltd.
SKU: 2007766815

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: Smooth ureteral access sheath with hydrophilic coating for easy insertion.

Wide Size Range: Available in sizes from 10Fr to 18Fr with various effective lengths.

Multiple Certifications: CE, ISO13485, and FDA certified for global market compliance.

Class II Medical Device: Registered as a Class II medical device for hospital use.

Single Use Design: Designed for single use to ensure patient safety and hygiene.

Ethylene Oxide Sterilized: Sterilized using Ethylene Oxide for guaranteed sterility.

OEM and ODM Services: Full customization available including samples, designs, and minor adjustments.

100% Quality Inspection: Every finished product undergoes visual and functional inspection.

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: ≤9.03h

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.