Combined Synopsis/Solicitation & Notice of Intent to Sole Source: Purchase of a Factory-Certified Refurbished HUMIMIC Starter Kit Control Unit

The FDA Office of Acquisition and Grant Services is soliciting the purchase of a factory-certified refurbished HUMIMIC Starter Kit Control Unit from TissUse GmbH in Berlin, Germany, under solicitation number 75F40126Q135669. This is a sole-source procurement because TissUse GmbH is the exclusive provider with access to the proprietary software source codes, diagnostic calibration fixtures, and engineering data essential for the proper factory recertification and maintenance of this specific hardware, making it impossible for any other commercial vendor to perform the required services. The acquisition is classified under NAICS code 334516 and is not subject to any set-aside requirements. The combined synopsis and notice of intent to sole source was posted on July 17, 2026, with responses due by August 1, 2026, at 6:00 p.m. Eastern Time. The contract will be performed at the agency’s location in Rockville, Maryland, and all inquiries should be directed to Suzanne Martella, the designated point of contact.