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OEM EM Ser ervice vices pre resentation sentation www.simeksmedical.com 1 Abo bout ut Simeks meks Intro rodu ducti tion on Established in 2010 with 42 years of experience in medical device sales and services Missi sion on To


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OEM EM Ser ervice vices pre resentation sentation

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Abo bout ut Simeks meks

Intro rodu ducti tion

  • n

Established in 2010 with 42 years of experience in medical device sales and services

Missi sion

  • n

To design, develop and manufacture high quality and innovative medical devices for global market

Focus

Specialized in the manufacturing of excellent interventional devices for interventional cardiology and radiology

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Market et Devel elop

  • pment

ent

Qualit lity Syst stem em Qualit lity Contr ntrol

  • l

Cust stom

  • mer

er 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 ur Ma Main in Values ues

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Cath theter er Di Division ision Tubin ing Set et Di Division ision

Pro roduction duction

  • Balloon Catheters
  • Stent Systems
  • Specialty Catheters
  • Other Interventional Products
  • Hemodialysis Bloodlines
  • Infusion Sets
  • Other Tubing Sets
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Tubin ing Set et Di Division ision

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Cath theter er Di Division ision

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201 2010 201 2011 201 2012 201 2013 201 2015

  • CoCr Coronary Stent
  • Stent Delivery System
  • Non-Compliant Balloon Catheter
  • .014ʺ Rx PTA Balloon Catheter
  • CoCr Coronary Stent (New Design)
  • Drug Eluting Coronary Stent
  • CTO Balloon Catheter
  • Diagnostic Catheter

201 2014

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

Balloon Catheter

  • .018ʺ Rx PTA Balloon Catheter
  • .018ʺ OTW PTA Balloon Catheter

Pro roduct duct Hi Histor story

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Bu Busi siness ness Mo Model del

Simeks 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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Wh What are re our ur OEM EM ser services vices?

OEM & Customized Product

We manufacture PTCA&PTA balloon catheters, stents and stent delivery systems in various combination according to client specifications

Technology Support

Simeks 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 ecification Options tions

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

  • .014ʺ Rx
  • .014ʺ OTW
  • .018ʺ Rx
  • .018ʺ OTW
  • .035ʺ OTW
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Identify

  • Size matrix
  • Customization

Decide

  • Balloon type
  • GW compatibility
  • Shaft type

Your Product

Reach your balloon catheter need without expensive R&D costs

Pr Product

  • duct De

Development elopment

fast way for your balloon catheter needs Fine Tune

  • Design adjustment

for requirements of the application area

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Balloon Shapes

Other than standard balloon shape, Simeks develops specific balloons best for your

  • applications. Elliptical, spherical or other

shapes are possible.

Catheter Design

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

Materials

Innovative 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

De Development elopment Options tions

for 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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Pr Process

  • cess Options

tions

Crimping

Simeks 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 Coating

Validated in-house ethylene

  • xide 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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Th Thanks nks for r Watching tching

info@simeksmedical.com