What certifications does the product have?

The product has CE, NMPA, and ISO 13485 certifications.

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Microapproach FSC Wholesale Medical Disposable Indeflator Ptca Balloon Inflation Device

Name: Microapproach FSC Wholesale Medical Disposable Indeflator Ptca Balloon Inflation Device
Brand: Shenzhen Microapproach Medical Technology Co., Ltd.
SKU: 2293876885

Guangdong, ChinaShenzhen Microapproach Medical Technology Co., Ltd.

US$3.80-7.00

100 Pieces

Sample price:US$12.00/set.Request sample

Product profile

Customization

Available

Type

Surgical Supplies Materials

Material

Plastic

Ethylene Oxide Sterilization

Quality Guarantee Period

Two Years

Group

Adult

Logo Printing

With Logo Printing

OEM

ODM

Deliver Time

2-3 Weeks

Transport Package

Bag + Carton

Specification

WK-24F

Trademark

Micro Approach

Origin

China

HS Code

9018391000

Production Capacity

2000PCS/Day

Key features

Ethylene Oxide Sterilization: Ensures high-level sterility for safe cardiovascular interventional surgery applications.

Two-Year Quality Guarantee: Provides a comprehensive 2-year warranty period covering mechanical defects and performance.

High Temperature Performance: Designed for easy inflation even in high-temperature environments for reliable operation.

Rapid Pressure Release: Features a mechanism for quick pressure release to enhance safety during balloon contraction.

Humanized Design: Modified ergonomic design fits comfortably in hand during extended surgical procedures.

OEM and ODM Acceptance: Accepts customized orders for branding and specific product configurations for global clients.

ISO 13485 Certified: Manufactured under ISO 13485 international quality system certification by German TUV.

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: ≤9.38h 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.