What is the product classification?

It is classified as a Class III medical device.

How is the product packaged?

Each unit comes in an individual pouch package.

What is the lead time for orders?

Peak season lead time is one month, while off-season is within 15 workdays.

Ptca and Pta Balloon Catheter

Name: Ptca and Pta Balloon Catheter
Brand: Shenzhen Alien Medical Technology Co., Ltd.
SKU: 2077507612

Guangdong, ChinaShenzhen Alien Medical Technology Co., Ltd.

US$25.00-50.00

100 Pieces

Sample price:US$50.00/piece.Request sample

Product profile

Customization

Available

Type

Surgery Instruments

Application

Endovascular

Model NO.

1.0-5.0mm

Material

Pebax

Feature

Disposable

Certification

CE, FDA, ISO13485

Group

Adult&Child

Sterilization

Eo Sterilization

Classification

Class III

Shelf Life

3 Years

Individual Package

Pouch

Transport Package

Box

Specification

1.0-5.0mm

Trademark

OBL/OEM

Origin

China

HS Code

90183900

Production Capacity

500000PCS/Year

Key features

CE, FDA, ISO13485 Certified: Meets international safety and quality standards for medical devices.

EO Sterilized: Ready for immediate use with Ethylene Oxide sterilization.

Class III Medical Device: High-risk device classified for critical medical applications.

3 Years Shelf Life: Ensures product stability and safety for up to 36 months.

Disposable Design: Single-use construction prevents cross-contamination.

Pebax Material: High-quality polymer ensures flexibility and durability.

Suitable for Adults & Children: Versatile application for various patient age groups.

Endovascular Application: Specifically designed for procedures within blood vessels.

Company profile

Shenzhen Alien Medical Technology Co., Ltd.

Guangdong, China

Business Type: Manufacturer/Factory, Trading CompanyExport Year: 2016-09-30Nearest Port: Shenzhen PortAverage Response Time: ≤24hTerms of Payment: T/T, PayPal, Western Union, etc.International Commercial Terms(Incoterms): FOB, EXW, CPT

AI-Powered supplier vetting

SummaryAlien Medical is presented as a medical-device supplier focused on cardiovascular and structural-heart products, with stated ODM capability and broad customization options. Its scope includes electronic products, smart-home and wearable products, and licensed research and sales of Class II and Class III medical devices. The supplier provides OEM services for well-known brands and reports export sales of 71%–90%, mainly to Africa, with service coverage listed for Somalia. Lead times are within 15 working days in both peak and off-peak seasons, and multiple payment and quotation terms are accepted. However, the available information identifies no management-system certifications, no SDK, no new products launched in the past year, no stock, overseas warehouse, overseas showroom, overseas agents or branches, and no offline trade-show participation. Quality-system evidence is incomplete: test equipment is reported as zero, while quality assurance and traceability statuses are unknown. Financial records are...

Supplier typeThe supplier is described as a professional medical-device supplier focused particularly on cardiovascular and structural-heart products. Its registered scope also covers electronic products, smart-home and wearable products, e-commerce, imports and exports, and licensed Class II and Class III medical-device research and sales, indicating a diversified but medically focused supplier profile.

CertificationsThe supplier management-system certification field is explicitly recorded as “NIL.” No certification holding is evidenced in the provided information.

After-Sales capabilityThe supplier accepts multiple quotation and payment terms and reports lead times within 15 working days in both peak and off-season periods. However, it has no stock, overseas warehouse, showroom, agents or branches; complaint handling has a procedure but no written records, and corrective/preventive-action procedures and records are absent.

Customization capabilityThe supplier explicitly provides OEM services for well-known brands, ODM services for customers with novel medical-device design requirements, and customization from samples, designs, full customization, minor customization and flexible customization. These statements directly support a broad customization offering.