oem services presentation - simeks medical€¦ · what are our oem services? oem & customized...
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About Simeks
Introduction
Established in 2010 with 42 years of experience in medical device sales and
services
Mission
To design, develop and manufacture highquality and innovative medical devices for
global market
Focus
Specialized in the manufacturing of excellentinterventional 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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2010
2011
2012
2013 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
2014
• .035ʺ OTW PTA Balloon Catheter• Semi-Compliant PTCA
Balloon Catheter
• .018ʺ Rx PTA Balloon Catheter
• .018ʺ OTW PTA Balloon Catheter
Product History
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Business Model
Simeks Brand:Simeks has CE certificates for allSimeks branded products. Theseproducts 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 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 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
.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 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 Shapes
Other than standard balloon shape, Simeksdevelops 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.
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
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 Simeksapplies is licensed from USA company. It is highly biocompatible, durable and lubricous.
Hydrophilic Coating
Validated 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.
