Opportunity
SAM #75F40126Q135669
FDA Sole Source: Refurbished HUMIMIC Starter Kit Control Unit and OEM Services from TissUse GmbH
Buyer
FDA Office of the Associate General Counsel for Administrative Law
Posted
July 17, 2026
Respond By
August 01, 2026
Identifier
75F40126Q135669
NAICS
334516, 423450, 334510
The FDA's Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP), Division of Cell Therapy 1 (DCT1), Cellular and Tissue Therapy Branch (CTTB) is seeking to procure a factory-certified refurbished HUMIMIC Starter Kit Control Unit from TissUse GmbH. - Government Buyer: - Food and Drug Administration (FDA), CBER, OTP, DCT1, CTTB - OEM Highlight: - TissUse GmbH (Berlin, Germany) is the sole source and manufacturer - Products and Services Requested: - HUMIMIC Starter Kit Control Unit (Product Code: D01-B), quantity: 1 - Supports advanced multi-organ-on-a-chip research with proprietary pneumatic control technology - HUMIMIC Care: Mandatory OEM recertification and technical service for the unit (one-off commercial transfer or OEM-designated equivalent refurbished unit) - HUMIMIC Starter M2.SSD replacement part: Hard drive preloaded with proprietary system firmware - Shared On-Site Travel and Service Expenses: Covers planned factory service visit for both the new and existing FDA units - Unique/Notable Requirements: - Only TissUse GmbH can provide the proprietary software, calibration fixtures, and engineering data required for recertification and maintenance - Includes on-site technical deployment and installation services - 1-year manufacturer warranty from FDA acceptance - Delivery required within 60 days after order - Offer prices must be held firm through September 30, 2026
Description
See attached Combined Synopsis/Solicitation & Notice of Intent to Sole Source: Purchase of a Factory-Certified Refurbished HUMIMIC Starter Kit Control Unit directly from the manufacturer: TissUse GmbH, Oudenarder Str. 16, Berlin, 13347 Germany as no other commercial source possesses the proprietary software source codes, diagnostic calibration fixtures, or engineering data necessary to execute the required factory recertification and maintenance for this specific hardware.