Memmert GmbH + Co.KG

Memmert GmbH + Co.KG specializes in laboratory and medical devices designed for controlled temperature and humidity environments. Their portfolio includes forced-air and convection ovens (such as the SN55plus, SN55plusX2, and SF110X2), climate chambers (like the SF75X2 and SF160plusX2), and specialized incubators (including the SN160plusX2). Some models, such as the SF450, are configured for multi-voltage use, catering to global applications in research, medicine, and industrial settings.

Memmert GmbH + Co.KG is headquartered in Germany, which places its devices under the jurisdiction of the European Union’s medical device regulations. Since the company’s products are listed in the EU’s eudamed registry, they must comply with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR) requirements applicable to their classification—Class I, Class IIa, or Class IIb—depending on the specific device’s risk profile and intended use.

Memmert’s medical devices are listed in the eudamed registry, the official EU database for medical devices. This listing ensures transparency and traceability for regulators, healthcare providers, and patients, as it confirms the device’s compliance with EU requirements. Listing in eudamed is mandatory for devices placed on the EU market, helping authorities monitor safety, performance, and post-market surveillance.

Memmert’s devices are classified under EU Class I, Class IIa, or Class IIb based on their risk level and intended use. Classification determines the regulatory pathway they must follow—for example, Class IIb devices require stricter scrutiny, including clinical evaluations and conformity assessments by a Notified Body, whereas Class I devices may have fewer requirements but still must meet essential safety and performance standards. The classification ensures appropriate oversight proportional to the device’s potential risks.