What certifications does the product have?

The product holds CE, ISO13485, and GMP certifications.

What is the lead time for orders?

The lead time is within 15 workdays for both peak and off-peak seasons.

Ce Certificated Urethral Dilator Package

Name: Ce Certificated Urethral Dilator Package
Brand: Hunan Reborn Medical Science and Technology Development Co., Ltd.
SKU: 902319105

Hunan, ChinaHunan Reborn Medical Science and Technology Development Co., Ltd.

US$0.01

1 Piece

Product profile

Customization

Available

Type

Surgical Supplies Materials

Material

PVC

Model NO.

reborn-dilator

Ethylene Oxide Sterilization

Quality Guarantee Period

Two Years

Group

Adults and Children

Logo Printing

with Logo or Without Logo

Color

Blue

Length

37cm

Transport Package

Carton Package

Specification

L37

Trademark

Reborn

Origin

China

HS Code

9018390000

Production Capacity

50000 Pieces/Year

Key features

Customizable Specifications: All specifications and lengths can be customized according to clinical needs.

Hydrophilic Coating: Attracts and holds liquids to create a low-friction, slippery surface for easy placement.

S-Curve Design: Supports the natural curvature of the male urethra for dilation of strictures.

Ethylene Oxide Sterilization: Comes pre-sterilized for immediate clinical use and patient safety.

Two-Year Warranty: Includes a comprehensive 2-year quality guarantee period for all units.

Multiple Sizes Available: Available in various sizes including F8, F10, F12, F14, F16, F18, F20, F22, F24.

CE and ISO Certified: Certified with CE, ISO13485, and GMP standards for medical device compliance.

OEM and ODM Support: Global cooperation available for custom branding and manufacturing requirements.

Company profile

Hunan Reborn Medical Science and Technology Development Co., Ltd.

Hunan, China

Business Type: Manufacturer/FactoryExport Year: 2016-06-01Nearest Port: GuangzhouAverage Response Time: ≤11.92hTerms of Payment: T/T, Western UnionInternational Commercial Terms(Incoterms): EXW

AI-Powered supplier vetting

SummaryThe supplier is identified as a Chinese manufacturer/factory operating in the health and medicine sector, with a stated production site in Zhuzhou, Hunan. It reports more than 10 production lines, 11–20 quality-control staff, and 21–30 years of combined R&D-engineer experience. ISO 13485 and GMP management-system certifications are stated, and OEM service is available. The product range focuses on urological and endourological devices, including ureteral access sheaths, stone baskets, guidewires, PCNL sets, and balloon dilatation catheters. The supplier states that it has self-operated import/export rights and began exporting in 2016, although exports account for only 21%–30% of total sales. Evidence of after-sales support, detailed innovation performance, audited financial strength, and a broad customer portfolio is limited. One trade record and one associated Ukrainian buyer are reported.

Supplier typeThe supplier is explicitly classified as a manufacturer/factory and as a limited company in China. Its associated industry is manufacturing, and the stated company name is Hunan Reborn Medical Science and Technology Development Co., Ltd., with another record identifying Hunan Ruibang Medical Technology Development Co., Ltd.

CertificationsThe supplier explicitly reports ISO 13485 and GMP certification of its management systems. These certifications are directly relevant to medical-device quality and manufacturing controls, although the slices do not provide certificate numbers, validity dates, or certification scopes.

R&D capabilityThe supplier reports 21–30 years of total R&D-engineer experience and lists multiple urological device products, including new products. These details support an established technical-development function, but no patents, R&D investment, product-launch record, or independently verified innovation outcomes are provided.

Production capacityThe supplier is identified as a factory with a stated physical production location, more than 10 production lines, and 11–20 quality-control staff. These explicit operational indicators support substantial production capability, while actual capacity utilization and product-specific output are not disclosed.

Customization capabilityThe supplier explicitly states that OEM service is available, providing direct evidence of customization support. The slices do not specify customization scope, minimum order requirements, tooling capability, development timelines, or examples of completed customized products.