Laboratory Products
Memmert INCO CO2 Incubator Classified as Medical Device
Feb 24 2012
As of now, the Memmert CO2 incubator is classified as a class IIa medical device for in vitro fertilisation and biosynthesis. 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 fertilisation, 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 basic safety requirements of the European Medical Devices Directive
93/42/EEC.
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