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www.simeksmedical.com 1 OEM Services presentation

Simeks OEM services - Balloon Catheter Company

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Page 1: Simeks OEM services - Balloon Catheter Company

1www.simeksmedical.com

OEM Servicespresentation

Page 2: Simeks OEM services - Balloon Catheter Company

2www.simeksmedical.com

About Simeks

IntroductionEstablished in 2010 with 42 years of

experience in medical device sales and services

MissionTo design, develop and manufacture high

quality and innovative medical devices for global market

FocusSpecialized in the manufacturing of excellent

interventional devices for interventional cardiology and radiology

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Market Development

Quality System

Quality Control

Customer

R&D

Simeks committed quality at the highest levels. Our company meet ISO 9001 and ISO 13485 standards and European Directive for Medical Devices 93/42/CEE. All our products are CE certificated.

Our R&D team includes talented engineers from different fields. They manage R&D projects and some projects are supported by science and technology agency of Turkey.

The dedicated QC team operates all QC inspections from raw material income to final inspections. Visual, dimensional and microbiological inspections are performed with qualified QC stuff and validated high-tech machines.

Additional to Simeks standards; customer specifies for the standards of the requested product. All specifications and QC tests can be applied according to customer demand.

Our Main Values

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Catheter Division

Tubing Set Division

Production

• Balloon Catheters

• Stent Systems

• Specialty Catheters

• Other Interventional Products

• Hemodialysis Bloodlines

• Infusion Sets

• Other Tubing Sets

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Tubing Set Division

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Catheter Division

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2010

2011

2012

2013 2015

• CoCr Coronary Stent

• Stent Delivery System• Non-Compliant Balloon Catheter

• .014 Rx PTA Balloon Catheterʺ• CoCr Coronary Stent (New Design)

• Drug Eluting Coronary Stent

• CTO Balloon Catheter

• Diagnostic Catheter

2014

• .035 OTW PTA Balloon Catheterʺ• Semi-Compliant PTCA Balloon Catheter

• .018 Rx PTA Balloon Catheterʺ• .018 OTW PTA Balloon Catheterʺ

Product History

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Business ModelSimeks Brand:Simeks has CE certificates for all Simeks branded products. These products are sold in domestic market as market leader. We also export our products to selected countries.

OEM Services:We utilize our expertise and abilities to supply customized products according to client needs.

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What are our OEM services?OEM & Customized ProductWe manufacture PTCA&PTA balloon catheters, stents and stent delivery systems in various combination according to client specifications

Technology SupportSimeks offers training and process transfer services to the clients for their sub-assembly operations

Private Label Product

Simeks offers private label products to clients who want to have to enhance

their brand with our support

Product Development & Prototyping

Our R&D team leads projects for our client ideas or design. We can assist our

client for new catheter development from idea to the product. Including

prototype and serial production

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Specification Options

Balloon Sizes Diameter from 1mm to 30mm

Length from 6mm to 220mm

Balloon Types Semi-Compliant

Non-Compliant / High Pressure

Compliant

CTO / Low Profile

Stent Delivery

Catheter GW Compatibility .014 Rxʺ .014 OTWʺ .018 Rxʺ .018 OTWʺ .035 OTWʺ

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Identify• Size matrix• Customization

Decide• Balloon type• GW compatibility• Shaft type

Your ProductReach your balloon

catheter need without expensive R&D costs

Product Developmentfast way for your balloon catheter needs

Fine Tune• Design adjustment

for requirements of the application area

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Balloon ShapesOther than standard balloon shape, Simeks develops specific balloons best for your applications. Elliptical, spherical or other shapes are possible.

Catheter DesignIf your project requires different catheter design, we are here to help you. Our R&D engineers develop catheters for specific projects.

MaterialsInnovative product needs advanced raw materials like low profile, multi-lumen tubing or reinforced tubing. Simeks has know-how on different raw materials and likes to try new ones.

Features for Application

Development Optionsfor your innovative product projects

Balloon catheters may look similar, however every application has its own challenges. Simeks know that by heart and design, test and validate the product in this respect.

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Process Options

CrimpingSimeks offers various options for catheter hub.

Our customers may use our standard hub which are injected directly over hypotubes or they can have catheters with their own hub design.

Hub – Insert Molding

Our hydrophilic coating will boost the performance of your interventional catheter.

Hydrophilic coating Simeks applies is licensed from USA company. It is highly biocompatible, durable and lubricous.

Hydrophilic CoatingValidated in-house ethylene oxide at your service for end products.

2 sterilization units and 21m3 total capability provide flexibility for fast product dispatches.

Sterilization

This process is made with high tech crimping machines and by skilled technicians.

Our engineers develops new crimping methods for different stent types.

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Thanks for Wathcing

[email protected]