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Suction-Evacuation Access Sheath Disposable
Negotiable
1,000 Pieces
Sample price:US$0.00/piece.Request sample
Product profile
Customization
AvailableType
CatheterMaterial
PlasticModel NO.
Ureteral Access SheathEthylene Oxide Sterilization
Ethylene Oxide SterilizationQuality 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
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
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:
Supplier replies will be sent to your registered email
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