What are the payment terms?

We accept T/T and L/C payment terms.

What is the lead time for production?

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

Is the product for single use?

Yes, this is a single-use medical device intended for hospital use.

Urological Access Sheath for Urology Surgery with CE

Name: Urological Access Sheath for Urology Surgery with CE
Brand: Haiyan Kangyuan Medical Instrument Co., Ltd.
SKU: 2011058105

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.

Urological 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

CE, ISO13485, FDA Certified: Meets international medical device standards for global market access.

5-Year Quality Guarantee: Comprehensive warranty coverage for 5 years from the date of purchase.

Ethylene Oxide Sterilized: Pre-sterilized using Ethylene Oxide for immediate clinical use.

Full Customization Available: Offers full customization, minor customization, and design-based options.

OEM and ODM Services: Manufacturer supports both OEM and ODM services with 22 R&D engineers.

Single Use Medical Device: Designed for single-use application in hospital settings.

Class II Medical Device: Registered as a Class II medical device for urological surgery.

100% Finished Product Inspection: All products undergo visual and functional inspection before shipment.

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: ≤10.38h

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.