Tentamus Pharma & Med Deutschland GmbHMedical devices: Determination of skin irritation and sensitisation

Tentamus Pharma & Med Deustchalnd GmbH offers a comprehensive and accredited test platform for the testing of medical devices according to the requirements of the EU MDR and DIN ISO 10993. We are specialised in the application of in-vitro test systems. We offer an accredited platform for the determination of skin irritation of medical devices in combination with the testing of potential allergenic (sensitising) effects. In this context we offer the following test platform

• Determination of cytotoxicity in vitro (ISO 10993-5)
• Determination of skin irritation in vitro on reconstructed human epidermis (ISO 10993-10 / ISO 10993-23)
• Determination of skin sensitisation: combination of OECD TG 442c (Direct Peptide Reactivity Assay), OECD TG 442d (Keratinosens Assay and OECD TG 442e (Human Cell Line Activation Test)

Tentamus Pharma & Med Deutschland GmbHAll showrooms

Details

Biological Safety Testing of Medical Devices

Biological Evaluation of Medical Devices / Biocompatibility TPMD provides a highly sophisticated and accredited in-vitro platform for testing of medical devices according to the DIN ISO...

Details

Medical devices: Determination of skin irritation and sensitisation

Tentamus Pharma & Med Deustchalnd GmbH offers a comprehensive and accredited test platform for the testing of medical devices according to the requirements of the EU MDR and DIN ISO 10993. We are...

Details

Bacterial Endotoxin & Pyrogens: Monocyte Activation Test

TPMD is accredited and GMP certified for the determination of bacterial endotoxin (BET) and non endotoxin pyrogens (NEPs). In addition to the classical Limulus Amoebocyte Test (LAL), we offer an in-ho...

Details

Medical Devices: Cytotoxicity & Genotoxicity

Tentamus Pharma & Med Deustchalnd GmbH offers a comprehensive and accredited test platform for the testing of medical devices according to the requirements of the EU MDR and DIN ISO 10993. We are...