Especially 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.
Memmert subjected its CO2 incubator ICOmed to a comprehensive medical device evaluation. Each Memmert CO2 incubator ICOmed is classified as a Class IIa medical device for the in vitro fertilisation (IVF) as well as biosynthesis.
Memmert is bringing medical devices of class IIa 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). The CE label on the appliances includes the mark 0197, denoting TRLP – TÜV Rheinland as the notified body.
Active humidity control ensures short recovery times after the door has been opened and minimises vaporisation in the interior. Together with the heating of the interior from all six sides and the heated inner glass door, it offers maximum protection for cell and tissue cultures and avoids the dangerous formation of condensation. The turbulence-free chamber ventilation ensures a constant and uniform atmosphere.
All parameters can be set easily and intuitively both with the operating display and the ControlCOCKPIT or the AtmoCONTROL software. The shutter box can be opened, allowing fast access to controls. Maintenance is possible even if the appliances are stacked. The incubator ICOmed has USB and Ethernet connections as well as a data logger with a ten-year storage capacity. Data can be read and programmes can be uploaded by remote access. Numerous features of the CO2 incubator ICOmed don’t let anything open to be desired:
Would you like to know more about the CO2 incubator ICOmed? In our webinar area, you will find the recording about the product presentation.
Memmert is bringing medical devices of class I according to EU Directive (EU) 2017/745 into circulation.
| Type | Intended use as medical device | Classification according to (EU) 2017/745 |
|---|---|---|
| UNmplus, UFmplus | The appliance may be used for heating fango, silicate and APS packs for physical therapy and keeping them warm. | I |
| UNm, UFm, INm, IFm | The appliance may be used for heating fango, silicate and APS packs for physical therapy and keeping them warm. | I |
| INmplus, IFmplus | Im may be used for heating fango, silicate and APS packs for physical therapy and keeping them warm. Implus may be used for temperature control of rinsing and infusion solutions and contrast agents. | I |
| IFbw | The appliance is used to heat non-sterile cloths and covers. Any other use is improper and may cause damage or danger. |
I |
Memmert is bringing medical devices of class IIa and IIb into circulation according to MDD 93/42/EEC until 31.12.2028 according to the transitional provisions (EU) 2023/607 by the (EU) 2017/745 article 120 (2).
| Type | Intended use as medical device | Classification according to 93/42/EWG |
|---|---|---|
| SNplus, SFplus | The product is intended for the sterilisation of medical devices with dry heat at atmospheric pressure. | IIb |
| SN, SF | The product is intended for the sterilisation of medical devices with dry heat at atmospheric pressure. | IIb |
| ICOmed | The CO2 incubator ICOmed is used to generate and maintain constant ambient conditions for the in-vitro fertilisation (IVF) application field, 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. | IIa |
As part of our medical device consultant training, we qualify you in the consultation, use and instruction of our medical products, taking into account the currently applicable legal requirements with regard to the new Medical Devices Regulation (EU) 2017/745. We explain the requirements for dealers, the geographical scope as well as information on the reporting system and the tasks of a medical device consultant. After successful participation, you will receive a certificate of qualification as a medical device consultant for Memmert medical devices.
Have we piqued your interest? Please contact us at sales@memmert.com for more information.
