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Biocompatible Material Urethral Dilator Package with CE and ISO
Negotiable
1 Piece

Product profile

Customization

Available

Type

Dilator

Material

PE

Model NO.

F8-F24

Ethylene Oxide Sterilization

Ethylene Oxide Sterilization

Quality Guarantee Period

Two Years

Group

Adults and Children

Logo Printing

with Logo or Without Logo

Color

Blue

Length

37cm

Size

F8-F24

Surface

Smooth

Transport Package

Plastic Package and Carton Package

Specification

F8 F10 F12 F14 F16 F18 F20 F22 F24

Trademark

Reborn

Origin

China

HS Code

9018390000

Production Capacity

50000 Pieces/Year

Key features

Biocompatible Material: PE material ensures better patient experience and safety.
Low Friction Design: Smooth surface and hydrophilic coating ease placement and reduce trauma.
Ergonomic S-Curve: Conforms to male physiological curve for natural urethral support.
CE & ISO Certified: Meets international standards with Ethylene Oxide sterilization.
Customizable Specs: Length and specifications can be customized per clinical needs.
2-Year Warranty: Comprehensive quality guarantee for two years.
100k Purification: Produced in 1,500 sqm aseptic workshops with strict QC.
OEM/ODM Support: Global cooperation with logo printing options available.

Company profile

Business Type: Manufacturer/FactoryExport Year: 2016-06-01Nearest Port: GuangzhouAverage Response Time: ≤11.96hTerms 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.

Product Q&A

Q:What is the material of the urethral dilator?
A:
The dilator is made of PE (Polyethylene), which is biocompatible and ensures a better patient experience.
Q:Is the product sterilized?
A:
Yes, all products are sterilized using Ethylene Oxide to ensure hygiene and safety.
Q:Can the size and length be customized?
A:
Yes, all specifications and lengths can be customized according to specific clinical needs.
Q:What is the warranty period?
A:
We provide a two-year quality guarantee period for this product.
Q:What are the available sizes?
A:
The standard sizes range from F8 to F24, with a standard length of 37cm.

Send Inquiry

*To:Hunan Reborn Medical Science and Technology Development Co., Ltd.Hunan Reborn Medical Science and Technology Development Co., Ltd.
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