The country of origin of a transfusion set

N357919 January 29, 2026 OT:RR:NC:N1:105 CATEGORY: Origin Zhi Hong Zhou BQ Plus Medical Co. Ltd No 18 Cheye Rd. Chedun Town Songjiang District China RE: The country of origin of a transfusion set Dear Mr. Zhou: In your letter dated January 17, 2026, on behalf of your client, Codan US Corporation, you requested a country of origin ruling for a transfusion set. The information provided in this ruling is similar to the facts presented in New York Ruling N355466, dated November 21, 2025. However, there are important distinctions in relation to the origin of the components which are described in further detail below. The item under consideration is described as a transfusion set, which is a single-use sterile device intended for the intravenous infusion of blood and blood-derived products, such as packed red cells, platelets, and plasma. It is designed to facilitate a safe and controlled transfusion procedure, including a 170-micron filter for filtration of micro-aggregates and clots. It connects to the blood bag via the spike and allows for manual flow control using clamps. The needle-free valve enables injection of additional medications, and the male Luer-lock ensures secure connection to the patient's catheter. The set is assembled in China in a certified cleanroom with components from China, Poland, and either Romania or Italy. The Chinese-origin components include the spike with cap (plastic piercing device), roller clamp (flow rate controller), slide clamp (flow on/off control), male Luer-lock (connector to patient catheter) and primary PVC tubing (2160mm medical grade tubing). The needle-free valve is made in Poland. The transfusion chamber (chamber with 170 micro filter) is made in either Romania or Italy. The manufacturing process starts with bonding the 2160mm PVC tubing with the spike, transfusion chamber, needle-free valve, and Luer-lock connector using cyclohexanone solvent. Next, the roller and slide clamps are added to the main tubing. Finally, leak testing, packaging, and ethylene oxide sterilization occurs. When determining the country of origin, the substantial transformation analysis is applicable. See, e.g., Headquarters Ruling Letter H301619, dated November 6, 2018. The test for determining whether a substantial transformation will occur is whether an article emerges from a process with a new name, character, or use different from that possessed by the article prior to processing. See Texas Instruments Inc. v. United States, 681 F.2d 778 (C.C.P.A. 1982). This determination is based on the totality of the evidence. See National Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993). Regarding the country of origin of the transfusion set, it is our opinion that the assembly process performed in China is not complex and does not constitute a substantial transformation. The process predominantly involves a simple combining of the various components. The combining of these parts in China does not create a new and different article of commerce with a name, character, and use distinct from the individual components. Therefore, to determine the country of origin of the transfusion set, we rely on the origin of the transfusion chamber, which provides the essential function of the set. It is the transfusion chamber from either Romania or Italy that allows for the safe passage of the red cells, plasma, and platelets without clots or micro-aggregates. While the tubing is also important, we find the filter performs the vital function and is also over half of the cost of the overall transfusion set. Accordingly, the country of origin of the transfusion set will be Romania or Italy depending on the sourcing of the transfusion chamber. The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP. This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact National Import Specialist Jason Christie at jason.m.christie@cbp.dhs.gov. Sincerely, (for) Denise Faingar Designated Official Performing the Duties of the Division Director National Commodity Specialist Division