Medalist® Medical Grade TPEs are the Premier Choice for Healthcare and Biopharma Applications
Medical device manufacturers increasingly turn to thermoplastic elastomers (TPEs) for applications that require flexibility or rubber-like elasticity, and they turn to Teknor Apex to deliver high quality, regulatory-compliant TPEs with a proven track record.

What differentiates Medalist from other TPEs?
These are Medical Grade Products:

  • Strict formulation control
  • Made with only FDA listed food grade ingredients
  • Biocompatible: ISO 10993-5 compliant
  • REACH SVHC and Proposition 65 compliant
  • CONEG and RoHS compliant (no heavy metals)
  • Does not contain phthalates, PVC, BPA and latex
  • Free of animal-derived materials (ADM-compliant)
  • Manufactured in multiple ISO-13485 certified facilities ensuring security of supply

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ISO 13485 Certifications

Medalist thermoplastic elastomers are manufactured in multiple locations, allowing for global reach and ensuring security of supply.  These facilities are ISO-13485 certified, which requires that our compounding operations focus on processes and procedures that maximize the safety and reliability of the compounds supplied to medical device manufacturers.

Download ISO 13485 certificates here:

ISO 13485

Applicable Facilities: Vermont
Scope: Thermoplastic Compounds (Medical, Healthcare & Regulated Markets)
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ISO 13485

Applicable Facilities: Singapore
Scope: Thermoplastic Compounds (Medical, Healthcare & Regulated Markets)
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