What are the main clinical applications?

It is used for PCNL, Percutaneous Nephrostomy, and Endopyelotomy.

Is the product disposable?

Yes, the product is designed as a disposable medical device.

Does the manufacturer offer OEM services?

Yes, OEM and ODM services are available for this product.

ISO13485 4f-32f Pcnl Renal Access Dilator and Sheath Introducer Set

Name: ISO13485 4f-32f Pcnl Renal Access Dilator and Sheath Introducer Set
Brand: Shenzhen Microapproach Medical Technology Co., Ltd.
SKU: 2299361715

Guangdong, ChinaShenzhen Microapproach Medical Technology Co., Ltd.

US$35.00-100.00

100 Sets

Sample price:US$10.00/piece.Request sample

Product profile

Customization

Available

Sterilization

Feature

Disposable

Model NO.

ARI-12F

Application

Clinical

Material

TPU

Certification

CE, ISO13485, Nmpa

Power Type

Without Power

Group

Adult

Tip Design

Available in Open Tip or Closed Tip (Tapered)

Components

Stent + Pusher + Guidewire (Standard Kit)

Adjustment Range

8cm to 32cm (Universal Adult & Pediatric)

Certificate

CE, Nmpa, ISO13485

Transport Package

Corrugated Carton

Specification

12F-30F

Trademark

Rapidguid

Origin

China

HS Code

9018390000

Key features

Zero-Resistance Access: Precision-tapered tip eliminates gaps for seamless transition to sheath.

Premium Kink-Resistant Sheath: High-quality PTFE with ultra-thin wall prevents collapsing under pressure.

Minimal Tissue Trauma: Sequential dilation reduces bleeding risk and surrounding tissue damage.

Excellent Visibility: High radiopacity allows clear monitoring of depth under fluoroscopy.

Frictionless Surface: Low-friction PTFE ensures zero drag for instruments and stones.

Wide Diameter Range: Available in 12F to 30F sizes for various clinical needs.

Multiple Certifications: Certified with CE, ISO13485, and Nmpa for global compliance.

Customizable Tip Design: Available in Open Tip or Closed Tip (Tapered) configurations.

Company profile

Shenzhen Microapproach Medical Technology Co., Ltd.

Guangdong, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service AvailableExport Year: 2015-09-02 CertifiedNearest Port: Shenzhen Port, Hong Kong Port, Guang Zhou PortAverage Response Time: ≤7.58h CertifiedTerms of Payment: LC, T/T, PayPal, etc.

AI-Powered supplier vetting

SummaryMicroApproach Medical is presented as a Shenzhen-based high-tech manufacturer focused on interventional medical products, including guidewires, catheters, introducer sheaths, and related equipment. The available information indicates established R&D activities, including a Japan R&D center, a stated medical-device quality management system, more than 10 production lines, and annual guidewire output of 4,000,000 pieces. Its export activity began in 2015, with exports representing 31%–40% of total sales. The supplier has documented transactions involving guidewires, introducer sheath kits, and Y connector sets with a Vietnam-based buyer, but the evidence does not establish the breadth of its after-sales service, customization process, formal certification portfolio, or overall customer base.

Supplier typeThe supplier is explicitly described as a national high-tech enterprise engaged in the R&D, production, and sales of interventional medical products. Its listed products include guidewires, catheters, introducer sheaths, interventional instruments, and related manufacturing equipment, indicating a specialized medical-device manufacturer rather than a general trading company.

R&D capabilityThe company states that it has strong R&D capability across polymer materials, biomedical engineering, and clinical medicine, maintains an R&D center in Japan, and continuously develops new products based on clinical requirements. These are explicit indicators of an established innovation orientation and technical development capability.

Production capacityThe supplier reports a 5,873.57 m² manufacturing plant, more than 10 production lines, 6–10 quality-control staff, and annual guidewire output of 4,000,000 pieces. It also states that it has established a high-quality production line for medical-device solutions, providing direct evidence of substantial production capability.

Client casesThe available trade records identify a Vietnam destination and one named buyer, CÔNG TY TNHH Y TẾ KHANG KHẢI, with transactions involving introducer sheath kits, a Y connector set, and a guidewire. These records provide evidence of at least one documented customer relationship and product shipments, but do not demonstrate a broad or independently verified customer portfolio.