MedTech Supplier Service Provider

TentaMedix GmbH

Am Hubengut 3
76149 Karlsruhe
Deutschland

Contact details

TentaMedix GmbH
Am Hubengut 3
76149 Karlsruhe
Deutschland

About us

TentaMedix GmbH

TentaMedix represents a new brand in the Tentamus network of life science laboratories.  TentaMedix emerges from the fusion of the bioanalytical testing labs MicroMol GmbH and Creamedix GmbH. In this context TentaMedix offers sophisticated bioanalytics in the field of  Biological Risk Assessment of Pharmaceuticals and Biologics with a strong focus on the biological safety testing of Medical Devices. TentaMedix is GMP certified and accredited according to the ISO 17025. In December 2019 TentaMedix GmbH received the official recognition document and listing by the ZLG as testing laboratory according to the guideline 93/42 EWG, 90/385/EWG and DIN ISO/IEC 17025 for biological and microbiological testing of medical devices.

Product / Service Portfolio

Accredited Medical Device Testing according to the DIN EN ISO 10993

  1. Chemical characterisation of Medical Devices  and determination of Leachables & Extractables (ISO 10993-13-15, 10993-17 / 18)
  2. Determination of Cytotoxicity in vitro (ISO 10993-5 / USP 87)
  3. Pyrogen testing: LAL- and Monocyte Activation Test (Ph. Eur. 2.6.14 / 2.6.30; ISO 10993-11)
  4. Determination of Bioburden and product specific recovery (ISO 11737-1 / 2)
  5. Skin testing on reconstructed human epidermis (Irritation and Corrosion): ISO 10993-10 / (-23 as draft) / OECD TG 431 / 439)
  6. Determination of Skin Sensitisation in vitro: KerationSens and h-CLAT-Test (OECD TG 442d / e)
  7. Determination of Hemocompatibility (ISO 10993-4) on human full blod in a dynamic and static model including determination of hemolysis, coaggulation and immune activation in several tests
  8. Determination of Genotoxicity (ISO 10993-3)
  9. Determination of occular Irritation in vitro (OECD TG 492 / OECD TG 460)

Approach

Phone number of TentaMedix GmbH