Memmert droogoven, (CO2)incubatoren en sterilisatoren

Memmert is al vele jaren DIN EN ISO 13485 gecertificeerd. De volgende producten zijn geclassificeerd als medisch hulpmiddel van klasse I volgens EU-richtlijn 93/42 / EEG.

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Intended use as medical device

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 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. 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).

 

Intended use as medical device

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

 

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

 

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