Memmert successfully has passed the extension of the MDD 93/42/EEC certificates. The existing EC certificate, directive 93/42/EEC was issued by the notified body and is now valid until May 2024 according to the transitional regulation (EU) 2017/745. The directive 93/42/EEC previously applied to medical device classes I, IIa and IIb. Memmert is bringing medical devices of class I according to the regulation MDR (EU) 2017/745 into circulation. Memmert is bringing medical devices of class IIa and IIb into circulation according to MDD 93/42/EEC until 26 May 2024 according to the transitional provisions by the (EU) 2017/745 article 120 (2). These are intended for the following purposes:
For Universal Ovens series UNm, UFm, UNmplus and UFmplus: The appliance may be used for heating fango, silicate and APS packs for physical therapy and keeping them warm.
For Incubators series INm and IFm: The appliance may be used for heating fango, silicate and APS packs for physical therapy and keeping them warm.
For Incubators series INmplus and IFmplus: The appliance may be used for temperature control of rinsing and infusion solutions and contrast agents.
For Sterilisers series SN, SF, SNplus and SFplus: The product is intended for the sterilisation of medical devices with dry heat at atmospheric pressure.
For CO2 Incubators series INCOmed: The appliance 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.
For Blanket Warmer series IFbw: The appliance may be used for heating non-sterile covers and cloths.
For CO2 Incubators series ICOmed: The appliance 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.
