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Medical Ureteral Access Sheath with High Quality for Single Use
Negotiable
1,000 Pieces
Sample price:US$0.00/piece.Request sample
Product profile
Customization
AvailableMaterial
PlasticEthylene Oxide Sterilization
Ethylene Oxide SterilizationModel NO.
Ureteral Access SheathQuality Guarantee Period
5 YearsGroup
AllLogo Printing
NegotiableUsage
HospitalFactory
YesRegistration Documents
AvailableMedical Classification
Class IISingle Use
YesCertification
CE, ISO13485, FDATransport Package
Packing: 5 PCS/Box, 20 PCS/CartonSpecification
10Fr-18FrTrademark
Madewell or OEMOrigin
Jiaxing Zhejiang ChinaHS Code
9018390000Production Capacity
600000 PCSKey features
Single Use Design: Designed for single use in hospital settings to ensure safety and hygiene.
Comprehensive Certifications: Holds CE, ISO13485, and FDA certifications for Class II medical devices.
Ethylene Oxide Sterilization: Sterilized using Ethylene Oxide to meet strict medical safety standards.
Wide Size Range: Available in sizes 10Fr to 18Fr with multiple effective length options.
OEM and ODM Services: Full customization, minor customization, and design-based options available.
100% Quality Inspection: Every finished product undergoes visual and functional inspection.
Manufacturer Direct: Direct supply from a manufacturer with 19 years of export experience.
Flexible Payment Terms: Accepts T/T and L/C payment methods for international transactions.
Company profile
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.
Product Q&A
Q:What is the usage scenario for this sheath?
A:
This ureteral access sheath is designed for single use in hospital settings.
Q:What certifications does the product hold?
A:
The product is certified with CE, ISO13485, and FDA as a Class II medical device.
Q:What is the minimum order quantity?
A:
The minimum order quantity is 5000 units.
Q:Can I customize the product?
A:
Yes, we offer full customization, minor customization, and options based on samples or designs.
Q:What are the available sizes?
A:
Sizes range from 10Fr to 18Fr with various effective lengths available.
Send Inquiry
*To:
Haiyan Kangyuan Medical Instrument Co., Ltd.
Haiyan Kangyuan Medical Instrument Co., Ltd.*Content:
Supplier replies will be sent to your registered email
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