As of now, the Memmert CO2 incubator INCO is recognised as a class IIa medical device for in vitro fertilization and gene expression. In addition to the CE mark, the devices are labelled with the number 1275, identifying LGA InterCert GmbH as the notified body.
Hardly any field of medicine moves us like reproductive medicine does. In the sterile and highly sophisticated environment of an IVF laboratory, new life is created, making it a matter of course that the quality requirements to be met there are extremely strict, in order to protect the sensitive ova, sperm and zygotes as best as possible.
For in vitro fertilization, the precision and reliability of the CO2 incubator are of crucial importance, as the slightest deviation in the CO2 atmosphere, temperature or humidity content during cultivation can already affect cell development. For this reason, Memmert has subjected its CO2 incubators INCO to a comprehensive evaluation process for their recognition as medical devices. The classification as class IIa medical device confirms that all Memmert CO2 incubators INCO comply with the essential safety requirements of the European Medical Devices Directive 93/42/EEC.
Exact intended use definition of the Memmert INCO as a medical device:
The CO2 incubator INCO is intended for the creation and maintenance of constant environmental conditions for application in the field of in vitro fertilisation (IVF), especially for the incubation of oocytes, spermatozoa and zygotes in special culture dishes for IVF application, as well as for gene expression and the biosynthesis of RNA and proteins.
