Nicon-Tec GmbH

Nicon-Tec GmbH specializes in producing surgical forceps under the SF series. These include single and paired configurations, available in sizes Small, Medium, and Large. The instruments are designed for general surgical procedures, offering versatility for various clinical applications.

Nicon-Tec GmbH is headquartered in Germany. The company’s location in Germany aligns with EU regulatory standards, ensuring compliance with medical device manufacturing and distribution requirements in the European market.

Nicon-Tec GmbH’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry tracks device information, including manufacturer details, device classifications, and regulatory status, ensuring transparency and traceability within the EU market.

Nicon-Tec GmbH’s surgical forceps fall under EU Class I medical devices. This classification applies because the instruments are considered low-risk, non-invasive tools used in general surgical procedures without significant risk to patient safety. Class I devices typically require less stringent regulatory oversight but still must meet essential safety and performance requirements.