Creamedix GmbH

Königsberger Strasse 2 | 76356 Weingarten - Germany

Tel:  +49 7244 60 82 65 | Fax: +49 7244 60 82 69

info@creamedix.eu | www.creamedix.eu

 


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Akkreditiertes Prüflabor für Biokompatibilitätstests

Biological Testing Services

We test your products, Our portfolio at a glance: 

  • Test of different materials as: Metals, polymers, ceramics etc.

  • Biological evalutation of medical devices according to DIN EN ISO 10993:
    Instruments, implants, tubes, 3D-printed parts, membranes, tissues etc.

  • Sample preparation according to DIN EN ISO 10993-12

  • in vitro-cytotoxicity according to DIN EN ISO 10993-5

  • Tests for irritation with recultivated 3D-human skin
    (epidermis) according to OECD test guideline 439 and DIN EN ISO 10993-10

  • Genotoxicity according to DIN EN ISO 10993-3 Ames test (OECD TG 471)

  • Hemocompatibility in a dynamic and static test design according to DIN EN ISO 10993-4

  • Endotoxin mediated Pyrogenicity according to USP 40-NF35:2017

 

  • Detailed test report

Which tests are relevant for the registration of your products?

The compilation of the optimal test portfolio for your product is part of a risk management procedure

which is based on the following table.

A detailed explanation of each test procedure you will find here.