Quality, safety and patient comfort
Minitube is MDR-ready, and we comply with the regulations of both MDD and MDR. Our technical documentation includes all risk management documentation, clinical evaluation and post market surveillance.
Minitube is registered as a medical device manufacturer with the U.S. Food and Drug Administration. We have several products registered with the FDA for sale and distribution in the USA, also known as 510(k) market clearance.
Our products are CE marked and classified in the EU as Class I products (non-sterile).
All our materials have been tested according to the following biocompatibility standards:
In vitro Cytotoxicity (ISO 10993-5)
Irritation and Skin Sensitization (ISO 10993-10)
Systemic Toxicity (ISO 10993-11)