Medical Device Qualified Supplier Directory


Trelleborg Sealing Solutions Company Profile
E: [email protected]
T: (310) 921-4170

2531 Bremer Rd., Fort Wayne, IN, 46803, United States
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Qualifications: ISO 9001, ISO 13485, FDA Registered, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows

Markets Supplied: North America, Europe, Worldwide


Trelleborg Sealing Solutions
Engineered Polymer Solutions for Healthcare & Medical

Trelleborg Sealing Solutions: Engineered Polymer Solutions for Healthcare & Medical
Medical, Biotech and Pharmaceutical Applications

Trelleborg Sealing Solutions develops, manufactures and supplies innovative engineered solutions for demanding medical, biotech and pharmaceutical applications in silicone, thermoplastics, and other polymers.

A leading developer and manufacturer of engineered sealing solutions for the healthcare & medical industry, Trelleborg is a trusted supply partner to customers producing a diverse range of applications. Positioned at the forefront of emerging trends, we keep our solutions ahead of industry standards and regulations. From a single global source, backed by the expertise of a worldwide engineering and manufacturing network, Trelleborg provides unrivalled local product development support to optimize solutions for healthcare & medical sealing and fluid handling challenges.

Trelleborg Sealing Solutions Overview

  • Over 5,500 employees
  • Over 25 manufacturing plants worldwide
  • ISO 9001:2008 and ISO/TS 16949:2009 quality certifications
  • Over 50 marketing companies offering global engineering support
  • Design engineering – Engineering expertise contributes to optimized product performance with innovative solutions
  • Combination Products: start-to-finish drug eluting product development and manufacturing in an FDA compliant facility
  • Local contact and global reach – Worldwide manufacturing with local technical support
  • 8 research and development centers globally
  • Research and development – Backing of global R&D facilities using latest FEA techniques
  • Rapid prototyping – Helps bring products to market faster
  • Worldwide Supply Chain Management (SCM) network
  • Offers on-time-delivery (OTD), advanced inventory control and special packaging
  • Materials expertise – Materials compliant to various healthcare & medical standards
  • In-house elastomer, polytetrafluoroethylene (PTFE) and polyurethane (PU) development
  • More than 2,000 proprietary materials engineered for specific industry requirements
  • Wide range of patented product designs for static and dynamic sealing applications
  • One-stop-shop – Large portfolio of product offerings allows supply base consolidation
  • Cost-effective – Lower costs through improved service life and innovative solutions
  • Liquid Silicone Rubber (LSR) – world leading player in high precision LSR technology

Material Certifications

  • ISO 10993
  • USP Class VI
  • FDA 21 CFR part 177
  • EU Reg (EC) 1935/2004
  • 3-A SSI Standards 18-03 & 20-25
  • NSF 51 & 61
  • Bundesamt für Risikobewertung (BfR)


  • Biotech
  • Diagnostics
  • Healthcare & Medical Tools
  • Medical Devices
  • Pharmaceuticals
  • Drug Delivery
  • Dialysis 
  • Respiratory
  • Orthopedic
  • In Vitro Diagnostics

Trelleborg Sealing Solutions is one of five business areas of the Trelleborg Group. The Trelleborg Group was founded in 1905 and has annual sales of approximately $3.60 billion in over 40 countries.

Materials: Elastomers, Thermoplastics and Advanced Composites

Based on decades of experience and working with leading equipment manufacturers and end users around the globe, Trelleborg Sealing Solutions has developed a tailor-made portfolio of materials to meet the demanding requirements of the healthcare & medical industry.

We provide a wide range of elastomeric and thermoplastic materials including filled and unfilled silicones, EPDMs, fluoroelastomers, polyester elastomers, nitriles, PTFE, PCTFE, ETFE, and polyurethanes. Products are available to seal liquid and gaseous media.

Within each material group various compounds and hardnesses are available to meet the requirements of specific applications including FDA, ISO, WRC, and other...

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