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igus® Ltd.

Caswell Road

Northampton, NN4 7PW

01604 677240

FDA and EU-10/2011-compliant for the medical, food and packaging industry



In order to comply with the strict requirements for food hygiene and food safety in both manufacturing and packaging, igus® has a developed a range of plastic solutions that conform to the specific guidelines. The FDA/ EU compliant materials have been specially developed for moving applications where there is either direct food contact or a possibility of food contact. As with all igus® materials, they do not require any lubrication therefore product contamination is ruled out completely.

Would you like more information about FDA specific products or do you need an individual consultation? Our experts will be happy to get in touch with you.
 

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FDA and EU compliant products

Plain Bearings

FDA and EU compliant plain bearings

  • Large range of FDA bearings
  • Sleeve and flanged options
  • High temperature and high chemical options. 

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Linear

A160UM FDA and EU compliant

  • Material: iglidur® A160
  • Compliant with FDA and EU regulations related to chemicals and food

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Knife Edge Rollers

knife edge rollers FDA and EU compliant

  • Available in various FDA materials
  • Tight deflection radii
  • Long serive life

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TH3 Chain

TH3 chain FDA and EU compliant

  • First hygienic design e-chain®
  • Operating temperature -40°C/ +70°C
  • Resistant to aggressive cleaning agents & chemicals

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3D print

3d filament FDA and EU compliant

  • High temperature material
  • Complies with the fire prevention requirements of the Federal Aviation Administration of the USA (FAA)

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iglidur® plastic rod

plastic rod FDA and EU compliant

  • Various FDA materials available.
  • For medium to high loads
  • Comply with FDA requirements
  • range from 10mm-100mm dia

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igubal®

igubal FDA and EU compliant

  • FDA inserts with stainless steel housing
  • Detectable material options
  • Various igubal® options available. 

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Tribo Tape

tribo tape FDA and EU compliant

  • FDA-compliant
  • Low coefficient of friction
  • Optional with adhesive tapes 

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xiros®

ball bearings FDA and EU compliant

  • Different FDA cages available. 
  • Smooth running
  • Low moisture absorption

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Dryspin

dryspin FDA and EU compliant products

  • Different sizes, threads & pitches available. 
  • Various nut material options
  • Suitable with multiple lead screw materials. 

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Other Solutions

FDA and EU compliant products

  • Stainless steel linear units
  • Various sizes available
  • Offered with FDA polymer liners

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Tribo Coating

tribo coating FDA and EU compliant

  • Good mechanical properties
  •  Protects parts against wear
  • Excellent wear and sliding properties 

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FDA and EU compliant products


FDA approval is achieved through a review of safety and effectiveness of products that go into the marketplace where it has been determined that the "benefits of the product outweigh the known risks for the intended use.". The body is responsible for protecting public health by regulating human & animal drugs and biologics, medical devices, tobacco products and cosmetics  

The EU 10/2011 legislation is different. This is a set of rules and regulations for plastic materials with intended contact with food products. It is a challenge for companies developing and manufacturing plastic food contact materials to demonstrate compliance with this regulation due to the complexity surrounding this intricate relationship of being able to understand the obligations and be able to demonstrate compliance. 

Only after each individual product has been approved by the PMA does it become an FDA & EU compliant product and will receive FDA certification.   

FAQ's

Frequently asked questions about FDA products

Contact our experts

Get in touch with our FDA experts!

Certificates

For all certificates and quality documents


Consulting

I would be happy to answer your questions personally

Shipping and consultation

In person:

Monday to Friday from 8am - 8pm.

Online:

24h