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Helix Medical
1110 Mark Ave.
Carpinteria, CA 93013 USA
Tel: +1 805 684 3304
Fax: +1 805 684 1934
Web: http://www.helixmedical.com
E-mail: sales@helixmed.com
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Custom Medical Device and Component Technology
Since 1984, Helix Medical, LLC, has been a leading global manufacturer for the medical device, health care, pharmaceutical and biotech industries. Manufacturing capabilities include silicone (LIM) and thermoplastic molding, extrusion, assembly, packaging, and sterilization in controlled environments. Headquartered in Carpinteria, CA, Helix Medical operates an FDA-registered medical device facility, certified to ISO 13485, with operations in North America and Asia and global product distribution.
Capabilities
Helix Medical manufactures custom LSR/HCR silicone and thermoplastic devices and components for the medical industry worldwide. Capabilities include LIM, compression/ transfer, insert, thermoplastic, and two-shot and micro molding, as well as extrusion, packaging, assembly, automation, and sterilization. For molding and extrusion, Helix Medical uses an extensive array of medical grade/implant grade silicones and thermoplastics. Our extrusion capabilities include single to multi-lumen tubing with varying profiles up to a 1¼ -inch outer diameter, as well as solid and striped radiopaque tubing which provides precision and tolerances suitable for the most demanding applications. Services include in-process inspection and minimal material waste.
Click here to view the Helix Medical capabilities brochure.
Thermoplastic injection molding is available at our Baldwin Park Operations and Asia Operations through APEC, A Division of Helix Medical, LLC. APEC specializes in two-shot molding (silicone to thermoplastic), insert molding, and high-end hot runner valve gate molds which eliminate waste and increase efficiency. APEC also offers rapid prototyping of thermoplastic components in both Southern California and China. Our Gloucester Operations facility in Gloucester, MA specializes in liquid injection molding (LIM) and thermoplastic injection molding as a component to a silicone-based part.
Helix Medical offers a wide range of value-added services from sterilization, assembly, and packaging to annealing, thermoforming, and pad printing.
Design and Engineering
Helix Medical offers fully integrated design, engineering and tooling capabilities to take you from concept through production quickly, efficiently and economically. Working from your drawing or solid model, we use an advanced CAD/CAM system to help design, prototype and fabricate silicone and thermoplastic components and assemblies of the highest quality. Coming up with solutions to meet even the most challenging design problems is one of our greatest strengths. We offer custom, in-house design and construction of molds, tools, and other equipment using the latest CNC technology.
Certifications/Quality
Our Carpinteria Operations at the Helix Medical headquarters facility in Carpinteria, CA is an FDA-registered medical device facility, certified to ISO 13485. Platinum-cured silicone products are manufactured following Good Manufacturing Practices (GMPs) in accordance with the Quality System Regulation in an FDA registered medical device facility. Products meet VSP Class VI biocompatibility requirements, and can be sterilized by steam, ethylene oxide, dry heat and/or gamma radiation within the user's validated cycles and exposure levels. These platinum-cured silicone products have full traceability to raw materials and contain no peroxide catalysts. Registered Medical Device Manufacturer (State-Federal FDA #2025182) Quality Systems certified to ISO 13485 quality standards.
HelixMark® Silicone Tubing and Fluid Handling Components
Helix Medical manufactures the HelixMark® brand of platinum-cured silicone tubing and fluid handling components for the pharmaceutical and biotech industry. The products are available in an extensive array of types and sizes including standard tubing, peristaltic pump tubing, braided reinforced tubing, close tolerance tubing, stoppers, and gaskets. HelixMark® products have been developed as a result of over 24 years of manufacturing experience and are fabricated from silicones made by industry leaders Dow Corning, Wacker, NuSil, and GE. We apply a medical device quality system to all product lines and include material certification and lot traceability with every product. Products are manufactured to meet USP Class VI biocompatibility requirements.
Click here to view the HelixMark® Silicone Products Catalog.
Therapeutic Market Specialties
Valued as a trusted source in the industry, customers rely on the expertise of Helix Medical for manufacturing products used in general surgery, bariatric surgery, cardiovascular surgery, plastic and reconstructive surgery, microvascular surgery, neurosurgery, oncology, nephrology, endoscopy, pain and wound management, anesthesiology, ophthalmology, cardiology, urology, orthopedics, ENT, OB/GYN, and IVD.
Categories this company is listed under in the European Medical Manufacturing Suppliers Directory:
- Components/Parts/Original Equipment Manufacturers: Catheters, cardiac (14 companies)
- Components/Parts/Original Equipment Manufacturers: Catheters, epidural (3 companies)
- Components/Parts/Original Equipment Manufacturers: Catheters, silicone (10 companies)
- Components/Parts/Original Equipment Manufacturers: Catheters, urological (20 companies)
- Components/Parts/Original Equipment Manufacturers: Gaskets (42 companies)
- Components/Parts/Original Equipment Manufacturers: Silicone components (39 companies)
- Moulding and Extrusion: Extrusion: Contract extrusion (72 companies)
- Moulding and Extrusion: Moulding services: Injection-moulding (235 companies)
- Moulding and Extrusion: Moulding services: Multicavity moulding (99 companies)
- Tubing: Silicone (52 companies)
