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 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 www.simeksmedical.com 2
Our ur Ma Main in Values ues Simeks committed quality at the highest levels. Our company meet ISO 9001 Qualit lity Syst stem em 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 Market R&D et Devel elop opment ent 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 Qualit lity Contr ntrol ol 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 Cust stom omer er requested product. All specifications and QC tests can be applied according to customer demand. www.simeksmedical.com 3
Pro roduction duction Tubin ing Set et Cath theter er Di Division ision Division Di ision • • Hemodialysis Bloodlines Balloon Catheters • • Infusion Sets Stent Systems • • Other Tubing Sets Specialty Catheters • Other Interventional Products www.simeksmedical.com 4
Tubin ing Set et Di Division ision www.simeksmedical.com 5
Cath theter er Di Division ision www.simeksmedical.com 6
Pro roduct duct Hi Histor story • Drug Eluting Coronary Stent • CTO Balloon Catheter • Semi-Compliant PTCA • . 035ʺ OTW PTA Balloon Catheter • Diagnostic Catheter Balloon Catheter 2011 201 2013 201 2015 201 2014 201 2010 201 201 2012 • .018 ʺ Rx PTA Balloon Catheter • CoCr Coronary Stent • Non-Compliant Balloon Catheter • • .018 ʺ OTW PTA Balloon Catheter Stent Delivery System • .014ʺ Rx PTA Balloon Catheter • CoCr Coronary Stent (New Design) www.simeksmedical.com 7
Bu Busi siness ness Mo Model del Simeks Brand: OEM Services: Simeks has CE certificates for all We utilize our expertise and Simeks branded products. These abilities to supply customized products are sold in domestic products according to client market as market leader. We also needs. export our products to selected countries. www.simeksmedical.com 8
Wh What are re our ur OEM EM ser services vices? Private Label Product OEM & Customized Product Simeks offers private label products to We manufacture PTCA&PTA balloon clients who want to have to enhance catheters, stents and stent delivery their brand with our support systems in various combination according to client specifications Product Development & Technology Support Prototyping Simeks offers training and process transfer services to the clients for their Our R&D team leads projects for our sub-assembly operations client ideas or design. We can assist our client for new catheter development from idea to the product. Including prototype and serial production www.simeksmedical.com 9
Specification ecification Options tions Balloon Types Catheter GW Compatibility Semi-Compliant .014ʺ Rx Non-Compliant / High Pressure . 014ʺ OTW Compliant . 018ʺ Rx CTO / Low Profile . 018ʺ OTW Stent Delivery .035ʺ OTW Balloon Sizes Diameter from 1mm to 30mm Length from 6mm to 220mm www.simeksmedical.com 10
Pr Product oduct De Development elopment fast way for your balloon catheter needs Decide Identify Fine Tune Your Product • Balloon type • Size matrix • Design adjustment Reach your balloon • GW compatibility • Customization for requirements of catheter need without • Shaft type the application area expensive R&D costs www.simeksmedical.com 11
De Development elopment Options tions for your innovative product projects Balloon Shapes Catheter Design Other than standard balloon shape, Simeks If your project requires different catheter develops specific balloons best for your design, we are here to help you. Our R&D applications. Elliptical, spherical or other engineers develop catheters for specific shapes are possible. projects. Materials Features for Application Innovative product needs advanced raw Balloon catheters may look similar, materials like low profile, multi-lumen however every application has its own tubing or reinforced tubing. Simeks has challenges. Simeks know that by heart and know-how on different raw materials and design, test and validate the product in this likes to try new ones. respect. www.simeksmedical.com 12
Pr Process ocess Options tions Hydrophilic Coating Sterilization Our hydrophilic coating will Validated in-house ethylene boost the performance of your oxide at your service for end interventional catheter. products. Hydrophilic coating Simeks 2 sterilization units and 21m 3 applies is licensed from USA total capability provide company. It is highly flexibility for fast product biocompatible, durable and dispatches. lubricous. Crimping Hub – Insert Molding Simeks offers various options This process is made with high for catheter hub. tech crimping machines and by skilled technicians. Our customers may use our standard hub which are Our engineers develops new injected directly over crimping methods for different hypotubes or they can have stent types. catheters with their own hub design. www.simeksmedical.com 13
Th Thanks nks for r Watching tching info@simeksmedical.com www.simeksmedical.com 14
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