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 26 May 2024 according to the transitional provisions by the (EU) 2017/745 article 120 (2).
The Memmert blanket warmer IFbw has an impressive range of safety features:
1.The heating capacity is limited to 80 ℃ to prevent cotton textiles from overheating if the blanket warmer is overloaded
2.Three platinum sensors monitor the surface temperatures in the hermetically sealed interior where the air is constantly circulated
3. An automatic open door sensor switches the heater and fan off if the door is opened
4. A mechanical temperature limiter interrupts the power supply at a maximum temperature of 85 ℃
Memmert blanket warmers IFbw are Class I medical devices. Memmert is bringing medical devices of class I according to the regulation MDR (EU) 2017/745 into circulation. According to the intended purpose, Memmert blanket warmers IFbw are suitable for warming non-sterile blankets and cloths.
Memmert is bringing medical devices of class I according to EU Directive 93/42/EEC into circulation until the regulation MDR (EU) 2017/745 comes into force. After the new regulation comes into force, Memmert will bring medical devices of class I into circulation according to MDR.
| Type | Intended use as medical device | Classification according to MDD |
|---|---|---|
| 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 | The appliance may be used for temperature control of rinsing and infusion solutions and contrast agents. | I |
| IFbw | The appliance may be used for heating non-sterile covers and cloths. | I |
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).
| Type | Intended use as medical device | Classification according to MDD |
|---|---|---|
| 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 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. | 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.
