What certifications does the product hold?

The product holds CE, ISO13485, and Nmpa certifications.

Is OEM or ODM service available?

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

8f-30f Amplatz Renal Dilator Introducer Set for Pcnl Percutaneous Kidney Stone Surgery

Name: 8f-30f Amplatz Renal Dilator Introducer Set for Pcnl Percutaneous Kidney Stone Surgery
Brand: Shenzhen Microapproach Medical Technology Co., Ltd.
SKU: 2302416385

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

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 tract establishment.

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

Minimal Tissue Trauma: Sequential dilation system reduces bleeding 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.

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

Universal Adjustment Range: Adjustable from 8cm to 32cm for both adult and pediatric use.

Comprehensive Certifications: Certified with CE, ISO13485, and Nmpa standards.

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: ≤7.60h 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.