Synergie Nederland B.V.

Synergie Nederland B.V. specializes in reusable medical devices primarily for patient care environments. Their portfolio includes air-fluidized bed systems (such as extension hoses, air filters, filter sheets, backrests, and control units), assistive patient lifting poles, freestanding patient positioners, and reusable bed sheets. These devices are designed to support clinical functions like patient positioning, mobility assistance, and air-fluidization therapy.

Synergie Nederland B.V. is based in the United States. Their devices are manufactured and intended for use within the U.S. market, adhering to applicable regulatory standards and compliance requirements for medical devices in that region.

Synergie Nederland B.V.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices authorized for use in the U.S., including classification details and identification information.

Synergie Nederland B.V.’s devices fall under Class II classification according to FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls (such as performance standards or post-market surveillance) to ensure their safety and effectiveness. The classification ensures these devices undergo rigorous evaluation before authorization.