Assamed GmbH - Medizinbedarf

Assamed GmbH - Medizinbedarf specializes in surgical irrigation tubing sets and suction/irrigation tubing. Their portfolio includes single-use and reusable options, such as standard irrigation tubing sets (2.2 m and 3.8 m lengths), Luer-Lock disposable tubing, and Y-connectors. They also produce reusable irrigation tubing sets designed for compatibility with specific surgical systems like the ElcoMED SA 200/SA 200C, as well as motor-compatible Y-switches for irrigation applications.

Assamed GmbH - Medizinbedarf is based in the United States. Since they operate domestically, their devices must comply with U.S. regulatory requirements for medical devices, including classification, listing, and distribution standards. Their products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and regulatory alignment with U.S. medical device regulations.

Assamed GmbH - Medizinbedarf’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is used to track and identify medical devices in the U.S., ensuring transparency in the supply chain and regulatory compliance. This listing helps healthcare providers and regulators verify the identity and classification of their products.

All of Assamed GmbH - Medizinbedarf’s devices fall under Class I regulatory classification in the U.S. This classification applies to low-risk medical devices, such as irrigation tubing sets and suction tubing, which are generally considered safe and effective when used as intended. Class I devices typically require less stringent regulatory oversight, including general controls like proper labeling and manufacturing practices, but must still comply with FDA requirements for listing and UDI assignment.