Memmert - a reliable partner in medicine It is our hard-lined commitment to quality that has made Memmert a reliable partner in the medical sector and medical research industry ever since the company’s founding in 1947. Of course we are DIN EN ISO 13485 certified since many years. The following products are classified as medical device. 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 31.12.2028 (EU) 2023/607 according to the transitional provisions by the (EU) 2017/745.
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.