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After decades of experience as a supplier to the medical industry for the production of blood suction tubes, medical drains, etc., it was a logical step to expand our range with the MEDI-GEHR® product line to include semi-finished products that meet the special quality and safety standards in the medical technology sector. For this purpose, our company headquarters in Mannheim and the US production site in Philadelphia were certified in 2016 and 2018 according to the requirements of a Medical Devices Quality Management System according to quality standard ISO 13485 for the production of semi-finished products. All MEDI-GEHR® products are suitable for medical and pharmaceutical applications with direct body contact with tissue, bone, skin and mucous membrane up to 24 hours.

OUR CERTIFICATIONS

All raw materials used for the medical grade products are food compliant (FDA, EU 10/2011), have been tested and evaluated by an independent, accredited testing laboratory and meet the following requirements for biocompatibility:

  • ISO 10993-1: Evaluation and testing within a risk management process
  • ISO 10993-5: Tests for in vitro cytotoxicity
  • ISO 10993-12: Sample preparation and reference materials
  • ISO 10993-18: Chemical characterization of materials
  • USP Class VI

During production, we use ultrasound to check our semi-finished products for defects and voids. As a manufacturer, we thus comply with special due diligence requirements which facilitates medical device manufacturers to obtain approval for their final products by reducing costs and time. We also attach great value to the traceability of stock goods leaving our production facilities. We also follow the VDI guideline for “Medical-grade Plastics”.

CUSTOMISED SOLUTIONS
We are particularly proud of the fact that, in addition to our stock shapes, we can also implement individual customer Solutions. Please contact us!

PRODUCT VARIANTS

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Tel: +49 621 87 89 - 0
Fax: +49 621 87 89 – 200

GEHR GmbH
Casterfeldstr. 172
68219 Mannheim
Germany

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info@gehr.de

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