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Suction-Evacuation Access Sheath Disposable
Negotiable
1,000 Pieces
Sample price:US$0.00/piece.Request sample

Product profile

Customization

Available

Type

Catheter

Material

Plastic

Model NO.

Ureteral Access Sheath

Ethylene Oxide Sterilization

Ethylene Oxide Sterilization

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.
Single Use Disposable Design: Ensures patient safety and prevents cross-contamination during procedures.
Ethylene Oxide Sterilization: Guarantees sterile condition upon delivery for immediate clinical use.
Comprehensive Size Range: Available in sizes 10Fr to 18Fr with multiple effective length options.
OEM and ODM Services: Flexible customization from samples, designs, or full specifications.
Class II Medical Device: Registered and classified for professional medical applications.
100% Finished Product Inspection: Rigorous visual and functional checks ensure zero defect delivery.
Established Manufacturer: Over 19 years of export experience with 279 employees and 10 production lines.

Company profile

Haiyan Kangyuan Medical Instrument Co., Ltd.
Importers and ExportersHigh Repeat Buyers ChoiceYears of Export ExperienceProduct Certification
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: ≤9.83h

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.

Product Q&A

Q:What certifications does the product have?
A:
The product holds CE, ISO13485, and FDA certifications.
Q:Is this product reusable?
A:
No, it is designed as a single-use disposable catheter.
Q:What is the minimum order quantity?
A:
The minimum order quantity is 5000 units.
Q:Can I request custom sizes or designs?
A:
Yes, we offer OEM and ODM services including customization from samples and designs.
Q:How is the product sterilized?
A:
It is sterilized using Ethylene Oxide.

Send Inquiry

*To:Haiyan Kangyuan Medical Instrument Co., Ltd.Haiyan Kangyuan Medical Instrument Co., Ltd.
*Content:
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