Is it OK to print my logo on package?

Yes. Please inform us formally before our production and confirm the design firstly based on our sample.

CE Certificated Disposable Silicone Double-Lumen Balloon Catheter

Name: CE Certificated Disposable Silicone Double-Lumen Balloon Catheter
Brand: Guangzhou ORCL Medical Co.,LTD
SKU: 1966119471

Guangdong, ChinaGuangzhou ORCL Medical Co.,LTD

US$0.88-1.15

1,000 Pieces

Product profile

Customization

Available

Type

1 Way 2 Way 3 Way

Material

Silicone

Ethylene Oxide Sterilization

Quality Guarantee Period

Three Years

Group

Adult

Logo Printing

Without Logo Printing

Usage

Disposable

Size

Fr6-Fr30

Quality Certification

Sterile

EOS

Properties

Medical Materials & Accessories

Feature

Disposable Surgery Instruments

Disinfecting Type

EOS

Safety Standard

En 149 -2001+A1-2009

Function

Surgery Medical

Instrument Classification

Class II

Balloon Volume

3ml-80ml

OEM

Accept OEM

Shelf Life

2 Years

Application

Urology Surgery

Certificate

CE / ISO 13485

Transport Package

Custom Packing2.1PC/Pouch, 10PC/Box, 500PC/Carton.

Specification

Fr6-Fr30

Trademark

ORCL

Origin

Guangdong, China

HS Code

9018390000

Production Capacity

500000 Piece/Pieces Per Day

Key features

CE & ISO 13485 Certified: Meets strict safety standards with CE and ISO 13485 certifications for medical devices.

Ethylene Oxide Sterilized: Sterilized via Ethylene Oxide (EOS) to ensure safety and hygiene for surgical use.

Disposable Silicone Material: Made from high-quality silicone, ensuring biocompatibility and patient comfort.

OEM Service Available: Supports OEM customization for branding and specific product requirements.

3-Year Quality Guarantee: Comprehensive quality assurance period covering three years for peace of mind.

Wide Size Range: Available in sizes Fr6 to Fr30 to suit various adult patient needs.

Fast Sample Delivery: Sample orders processed within 3-5 days for quick quality verification.

Flexible Shipping Options: Supports DHL, UPS, FedEx, TNT, air, and sea shipping for global delivery.

Company profile

Importers and ExportersYears of Export ExperienceSelf-brandedExhibition Experience

Guangzhou ORCL Medical Co.,LTD

Guangdong, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc. CertifiedExport Year: 15 Years CertifiedNearest Port: Nansha PortAverage Response Time: ≤6.70h

AI-Powered supplier vetting

SummaryORCL demonstrates established medical-device quality, production, customization, and service-management capabilities. It reports EU TUV South German ISO13485 certification, EU CE (0123) certification, China NMPA registration, and China National High-tech Enterprise certification. The supplier has six quality assurance and quality control inspectors, multiple manufacturing lines, valid contracts with associated subcontractors, inventory capability, and one-month lead times in both peak and off-season periods. It supports OEM and ODM services and offers extensive customization. Service procedures for supplier approval, corrective and preventive actions, complaints, and capability assessment are documented and followed. However, the evidence also shows no available SDK, no new products in the past year, no overseas warehouse, showroom, agents, or branches, and zero stated countries for overseas services. Financial records are identified by year, but financial strength cannot be assessed from the provided...

Supplier typeThe supplier is presented as a medical-device manufacturer with its own-brand quality-control capability, OEM services for popular brands, product development and design, production-process management, and a complete medical-device product lifecycle capability. Its stated certifications and medical patents further support classification as an established medical-device supplier.

CertificationsThe supplier explicitly reports EU TUV South German ISO13485 quality management system certification, EU CE (0123) certification, China NMPA medical-device registration, and China National High-tech Enterprise certification. These certifications directly support a positive assessment for certification holding.

After-Sales capabilityThe supplier has documented and followed procedures for corrective and preventive actions, customer complaints, supplier approval, and service-capability assessment. It also reports inventory capability and one-month lead times in both peak and off-season periods, but lacks overseas warehouses, showrooms, agents, and branches; therefore, the evidence supports structured service handling but not broad overseas after-sales coverage.

R&D capabilityThe supplier reports more than 50 medical-related patents, industry-university-research cooperation, product development and design capabilities, and ODM service availability. However, it also states that no new products were developed in the past year and that no SDK is available, so the evidence supports underlying R&D resources but indicates limited recent product innovation.

Production capacityProduction evidence includes six quality inspectors, injection molding, blow molding, extrusion, packaging, spring manufacturing, and one-way valve assembly equipment, along with valid contracts with associated subcontractors and inventory capability. The supplier also reports one-month lead times in both peak and off-season periods and production-process management across the product lifecycle.

Customization capabilityThe supplier explicitly offers customization from samples, customization from designs, full customization, minor customization, and flexible customization. It also provides ODM services, giving direct evidence of broad customization and design-manufacturing support.

Client casesThe supplier reports OEM service for popular brands and participation in the 2024 Arab Health offline trade show. These are direct examples of market-facing experience, but the slices do not identify specific customer names, order outcomes, or detailed case results.

Product Q&A

Q:Can I have a sample order?

Yes, we welcome sample order to test and check quality. Mixed samples are acceptable.

Q:What about the lead time?

Sample needs 3-5 days, mass production time needs 2-4 weeks for order quantity more than10,000 pcs

Q:Do you have any MOQ limit for this item?

Low MOQ, 1pc for sample checking is available

Q:How do you ship the goods and how long does it take to arrive?

We usually ship by DHL, UPS, FedEx or TNT. It usually takes 3-5 days to arrive. Airline and sea shipping also optional.

Q:How to proceed an order for dedical consumables?

Firstly let us know your requirements or application. Secondly We quote according to your requirements or our suggestions. Thirdly customer confirms the samples and places deposit for formal order. Fourthly We arrange the production.