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Our experience with Class I, II and III medical devices, streamlines the product development process and facilitates quicker product design turnaround.
Our extensive level of capabilities includes:
Polymer Assembly Equipments
We process a wide variety of medical grades polymers from soft urethanes to hard nylons and appropriate materials are selected to match the desired properties of the finished product either it is strength, flexibility, radio-compatibility, biocompatibility or sterilization compatibility.
Our automated machines allow for:
- heat welding
- laser welding
- tubing necking/stretching
- marker band swaging
- stent crimping,
- adhesive bonding
- balloon folding
- spray or dip coating
- inkjet, pad or laser marking
- tipping amongst others
We are experienced with the following polymers: Nylon, Pebax, PEEK, PET, Urethanes, PTFE, Polyethylene, PLLA and much more.
Medical Balloons
We are specialized in the design, development and manufacturing of medical balloons used in a variety of procedures such as PTCA, PTA, occlusion, ureteral dilatation, endoscopy dilatation, drug delivery and other medical specialty requiring thin walled, high quality medical balloons.
Our high burst resistance balloons are made from materials such as Nylon, Pebax, PET, Urethane or other proprietary materials. Each material is carefully chosen to meet the desired finished specification whether it is thin walls, low profile, flexibility, controlled compliance or high burst pressure.
Our typical balloon capability includes:
- Diameters: from 0.5 to 50mm
- Burst pressure: up to 500psi
- Lengths: any up to 350mm
- Wall thickness: 0.0002 – 0.005”
We can produce a wide variety of balloon shapes, body styles, lengths and can custom design a balloon to meet your specifications.
Testing Equipments
To assess the finished device functional performance or to check whether the product is meeting its intended specification, Envaste uses a wide variety of inspection and testing equipments including:
- Automated visual inspection system
- HBLT hydraulic burst tester
- Tensile tester
- Interventional Device Testing Equipment (IDTE)
- GPL gas leak tester, amongst others.
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