I am looking for components, such as tubes, wires or connectors. Can you offer me these?

Yes, we can provide components or raw materials.

What is your payment term?

EXW quotation, 100% T/T payment in advance.

How many countries are your products used?

We have customers all over the world.

PTFE Coated Guidewires with FDA &ISO13485 Certification

Name: PTFE Coated Guidewires with FDA &ISO13485 Certification
Brand: Nanos Biomaterial (Suzhou) Co., Ltd.
SKU: 2131959765

Jiangsu, ChinaNanos Biomaterial (Suzhou) Co., Ltd.

US$4.20-21.00

100 Pieces

Product profile

Customization

Available

Type

Surgical Supplies Materials

Material

Nickeltitanium Wire Core

Ethylene Oxide Sterilization

Quality Guarantee Period

Two Years

Group

Adult

Logo Printing

With Logo Printing

OEM

Accept OEM

After-Sale Service

Free Spare Parts

Approval Scope

Class III

Sample

Free

Transport Package

Double PE Bag and Carton

Specification

Customized

Trademark

Origin

China

HS Code

7326201000

Production Capacity

1500000PCS/Year

Key features

Flexible Customization: Specifications like dimensions, OD, and coating can be customized to meet specific requirements.

FDA & ISO Certification: Product holds FDA approval and ISO 13485 certification for quality assurance.

X-Ray Visibility: Distal tip is visible under X-ray to assist physicians with positioning and movement.

Dual Coating Technology: PTFE coating on proximal end and hydrophilic coating on distal segment reduce friction.

Shapeable Distal Tip: Tip can be shaped per standard technique to form a 'J' shape for accurate positioning.

Premium Material Core: Constructed with Nitinol alloy, stainless steel, and platinum-tungsten alloy for durability.

Two-Year Quality Guarantee: Comprehensive quality guarantee period of two years for all products.

Ethylene Oxide Sterilization: Sterilized via Ethylene Oxide for single-use safety and compliance.

Company profile

Nanos Biomaterial (Suzhou) Co., Ltd.

Jiangsu, China

Business Type: Manufacturer/Factory, Trading CompanyExport Year: 2019-01-21Nearest Port: shanghaiAverage Response Time: >24hTerms of Payment: LC, T/T, Western Union, etc.International Commercial Terms(Incoterms): FOB, EXW, CIF

AI-Powered supplier vetting

SummaryNanos Biomaterial (Suzhou) Co., Ltd. is identified as a China-based manufacturer/factory and trading company focused on medical-device components and related products. Evidence indicates ISO 13485 and GMP certifications, more than 10 production lines, automated hypotube and PTFE coating production, and stated export activity. The supplier offers customized steel-tube specifications and proximal/distal designs, as well as OEM/ODM services. Its stated product and technology scope includes hypotubes, PTFE/Parylene products, balloon catheters, guide wires, and other medical components. Information is insufficient to confirm after-sales service capability, financial credibility, or specific customer cases. The provided registered-capital amount is excluded from this assessment in accordance with the privacy instruction.

Supplier typeThe supplier is described as a factory and as both a trading company and manufacturer/factory. It operates in medical manufacturing in Suzhou, China, while the associated Nanos Medical head office is listed in Shanghai, indicating a manufacturing-oriented supplier structure with medical-device business coverage.

CertificationsThe supplier explicitly states that it has passed ISO 13485 and GMP certification, and these certifications are also listed as its management-system certifications. This directly supports compliance capability for medical-device manufacturing.

R&D capabilityNanos Medical describes a focus on technological innovation and holistic surgical solutions. The supplier also reports advanced balloon-catheter and guide-wire equipment and processes, PTFE/Parylene coating capabilities, laser cutting, taper grinding, R&D engineers, and customized proximal/distal designs, providing direct evidence of product and process development capability.

Production capacityThe supplier reports a highly automated hypotube and PTFE coating production line, large capacity, stable quality, more than 10 production lines, and lead times of within 15 working days off-peak and one month during peak periods. Its product range covers multiple medical components, supporting a positive assessment of manufacturing breadth and capacity.

Customization capabilityThe supplier explicitly offers flexible customization of steel-pipe specifications and proximal/distal designs according to customer requirements. It also provides OEM/ODM services and customized PTFE/Parylene coating and related processing, directly demonstrating customization capability.

Product Q&A

Q:What products do you offer?

We offer a wide range of interventional medical devices core parts, including Hypotube, Wire, Mandrel, and medical devices of OEM/ODM service, including PTCA, NC PTCA, CTO, PTA/HP PTA balloon catheter. We also provide medical raw materials or their machining parts.

Q:What certificates do you obtain?

ISO 9001, ISO 13485, GMP certificates

Q:What is your minimum order quantity (MOQ)?

500pcs for parts, 100pcs for devices

Q:Are your products sterilized?

Yes, we can provide products after EO sterilized.

Q:I'm a distributor and I need validate your products prior to distributing in my region. Would you send me free samples?

In most cases, we offer ten parts or one device sample for evaluation. Express fee will be paid by clients.