In addition to the global presence with our own brand interventional balloon catheters, Simeks also provides OEM services to other medical device manufacturers. We offer our expertise in the design, development, and production of high-quality balloon catheters through these services.
Simeks supplies customized products and provides new product development services to other manufacturers. Our flexible and solution-oriented approach makes it possible to fulfill distinctive requests.
Simeks is certified according to EN ISO 13485. Commercial Simeks balloon catheters are CE certificated.
Choosing Simeks as a partner for your products saves you significant time and cost.
Our coherence to the quality management system reinforces OEM projects with documents in compliance with regulatory requirements, making the certification process easier for the final product.
This cooperation model provides a fast track to the end product and regulatory preparation for customers. Simeks provides the OEM version of its commercial product and access to its technical documentation, which the customer can use on their project.
As a result, customers can easily have a new product on the market with their brand name and certification.
It is a great option for other medical device manufacturers which intend to add these products to their catalog without a lengthy and costly product development process and with minimal regulatory work.
If the customer wants to differentiate their product from standard Simeks product or the other products in the market, we present customization options to fulfill the requests of the customer.
It is possible to customize colors, add additional balloon sizes and adjust some technical specifications of the standard catheters without getting into a product development process.
( DESIGN / DEVELOPMENT / PROTOTYPING )
Simeks can take your medical device project from the initial idea to the end product on the market. When customers have an exclusive design idea, a new solution to an existing clinical need, or a performance target to achieve, Simeks can plan and manage a product development project by sharing its R&D and manufacturing knowledge.
Bring your own (unique) balloon catheter idea to life.
• Product design, development, and (rapid) prototyping;
• Provided/guided by Simeks balloon catheter production professionals
CUSTOM BALLOON FORMING / PRODUCTION
Balloon diameter options ranging from 1 mm to 30 mm
Balloon length options between 5 mm to 300 mm
Various shapes: standard, cylindrical, spherical, tapered, or custom.
Dedicated functions / medical uses: non-compliant, high-pressure, semi-compliant, compliant, CTO.
CUSTOM CATHETER SHAFT PRODUCTION
Compatible with various guidewire sizes: .014" / .018" / .035" / .038"
• Rapid exchange (RX)
• Over-the-wire (OTW) [Coaxial, D-lumen]
Stent delivery catheter custom-tailored for your coronary stent
RECENT OEM PROJECT EXAMPLES
PTCA balloon dilatation catheters
PTA balloon dilatation catheters
PTV (Valvuloplasty) balloon catheters
Balloon catheters for Drug-Coated Balloon (DCB) projects
SDS (Stent Delivery System) for balloon-expandable coronary or peripheral stents
TAVI Delivery Systems (Balloon catheter for balloon-expandable TAVI devices)