The country of origin of a transfusion set

N355466 November 21, 2025 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 April 22, 2025, on behalf of your client, Codan US Corporation, you requested a country of origin ruling for three medical products. The first two items were addressed in New York Ruling N355059. Additional information was provided by email dated October 22, 2025. 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 200-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. The Chinese components include the spike with cap (plastic piercing device), transfusion chamber (chamber with 200 micro filter), roller clamp (flow rate controller), slide clamp (flow on/off control), and the male luer lock (connector to patient catheter). The needle free valve can be made in Poland or China. The primary PVC tubing (2160mm medical grade tubing) is made in South Korea. The manufacturing process starts with bonding the 2160mm PVC tubing with the spike, transfusion chamber, needle free valve, and luer 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 China 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. Accordingly, the country of origin of the transfusion set will be China. 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) Deborah Marinucci Designated Official Performing the Duties of the Division Director National Commodity Specialist Division