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Endoscopy 0.035 Inch 4500mm Ercp PTFE Zebra Nitinol Disposable Guide Wire with FDA Mdsap ISO13485

Name: Endoscopy 0.035 Inch 4500mm Ercp PTFE Zebra Nitinol Disposable Guide Wire with FDA Mdsap ISO13485
Brand: Zhejiang Soudon Medical Technology Co., Ltd.
SKU: 2042239295

Zhejiang, ChinaZhejiang Soudon Medical Technology Co., Ltd.

US$32.50-44.00

50 Pieces

Sample price:US$44.00/piece.Request sample

Product profile

Customization

Available

Type

Guide Wire

Material

Nitinol, PTFE

Model NO.

SD-06-89-A450J

Ethylene Oxide Sterilization

Quality Guarantee Period

Two Years

Group

Adult

Logo Printing

With Logo Printing

Max.O.D.

0.035 Inch

Working Length

4500mm

Color

Yellow-Black

Special Material

PTFE

Model Shape

Transport Package

Bag+Inner Box

Specification

160mm*104mm for individual product packaging

Trademark

Soudon/OEM Brand

Origin

China, Zhejiang Province

HS Code

9018390000

Production Capacity

1000000PCS/Year

Key features

Low Friction Design: Diameter 0.78-0.79mm ensures higher smoothness and better passability than industry standard.

Flexible Tip Performance: Flexible spring in head end provides good cornering performance and easy navigation.

High Visibility Pattern: Typical black and yellow stripes make guidewire movement clear to see during procedures.

Certified Quality: FDA, Mdsap, ISO13485, CE, CFDA, and SGS certified for safety and reliability.

Customization Options: OEM and ODM services available with flexible customization from samples or designs.

Professional Manufacturer: Direct factory with R&D capabilities and strategic partnerships with top universities.

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

Company profile

National Award receivedFast DeliveryFull CustomizationManagement Certification

Zhejiang Soudon Medical Technology 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: 4 Years CertifiedNearest Port: Shanghai Port, Ningbo PortAverage Response Time: ≤6.98h

AI-Powered supplier vetting

SummaryThe supplier is a combined company engaged in medical-device-related production and sales, including licensed Class II and Class III medical-device activities. It demonstrates broad customization and ODM capability, reports new-product development within the past year, and has OEM experience with well-known brands. Service procedures for corrective actions, complaints, supplier assessment, and finished-product inspection are documented and followed. However, the supplier reports no quality assurance in its quality-control processes, has only two quality-control inspectors, and lacks in-stock capacity, overseas warehouses, overseas agents or branches, and overseas service coverage. Manufacturing capacity is also weakened by the absence of a valid contract with affiliated subcontractors. Financial credibility cannot be assessed from the provided information.

Supplier typeThe supplier is identified as a combined company. Its stated business scope includes production and operation of Class II and Class III medical devices, as well as hygiene products and disposable medical supplies subject to required approvals.

After-Sales capabilityThe supplier has documented and followed procedures for corrective and preventive actions and customer complaints, and it has written procedures and records for supplier-service assessment. However, it reports no in-stock capacity, overseas warehouse, overseas showroom, overseas agent or branch, and zero countries with overseas services, limiting demonstrated international after-sales coverage.

R&D capabilityThe supplier reports new products within the past year, offers ODM services and broad design support, and holds one national science and technology progress award. Its stated emphasis on innovation is consistent with these capabilities, although it has no available SDK.

Production capacityProduction-related evidence includes assembly-line and precision-workshop facilities, two quality inspectors, standardized finished-product inspection instructions, and OEM service for well-known brands. Deficiencies include no stated quality assurance in quality-control processes, no in-stock capacity, and no valid contract with affiliated subcontractors; the business scope nevertheless includes licensed medical-device production activities.

Customization capabilityThe supplier explicitly offers customization from samples, customization from designs, minor customization, flexible customization, and full customization. The same broad design-service range is reported in both R&D and facility-related information, providing clear evidence of extensive customization capability.

Client casesThe supplier reports OEM service for well-known brands and participation in the CMEF offline trade show. These are identifiable customer or market-exposure indicators, but no customer names, project descriptions, order volumes, or verifiable case details are provided.