Endoscopy Accessories Single Use Stone Retrieval Balloon Catheter for Ercp with ISO13485 Mdr Cfda

Name: Endoscopy Accessories Single Use Stone Retrieval Balloon Catheter for Ercp with ISO13485 Mdr Cfda
Brand: Zhejiang Soudon Medical Technology Co., Ltd.
SKU: 1924079271

Zhejiang, ChinaZhejiang Soudon Medical Technology Co., Ltd.

US$50.00

50-499 Pieces

US$49.00

500-999 Pieces

US$48.00

1,000+ Pieces

Product specifications

SD-10

Sample price:US$100.00/piece.Request sample

Product profile

Customization

Available

Type

Stone Retrieval Balloon Catheter

Material

Latex Balloon

Model NO.

SD-10-T121518A

Ethylene Oxide Sterilization

Quality Guarantee Period

Two Years

Group

Adult

Logo Printing

With Logo Printing

Working Length

2 Meters

Channel Od

3.2mm

Balloon Max Od

12mm, 15mm, 18mm

Volume

1.6ml, 2.6ml, 5ml

Tuebe Od

7.5 Fr

Transport Package

Protection Tube+PP Bag+Inner Box+Outer Carton

Specification

3.2mm Channel OD x 2 meters Length

Trademark

Soudon

Origin

China

HS Code

9018903090

Production Capacity

500000PCS / Month

Key features

ISO 13485 & FDA Certified: Compliant with CE, FDA, MDSAP, and ISO 13485 quality standards.

Triple Lumen Design: Integrates guidewire, liquid injection, and balloon lumens for multi-function use.

Radiopaque Markers: Markers at both ends enable accurate positioning under X-ray fluoroscopy.

Tapering Tip Design: Improves insertion performance into the duodenal papilla.

Multi-Size Options: Balloon OD available in 12mm, 15mm, and 18mm with various volumes.

OEM/ODM Service: Private logo and label printing available on packaging with authorization.

Ethylene Oxide Sterilized: Sterile, non-toxic, non-pyrogenic, and for single patient use only.

Fast Lead Time: Typical production lead time is within 7 working days.

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: ≤8.88h

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.