The country of origin of a single-use, medical tubing set.

N362806
July 22, 2026
OT:RR:NC:N3:143
CATEGORY: Origin Ryan Supek TE Connectivity Corporation 2800 Fulling Mill Road Middletown, PA 17057 RE: The country of origin of a single-use, medical tubing set. Dear Mr. Supek: In your letter dated May 21, 2026, you requested a country of origin ruling of a single-use, medical tubing set, part number 20034352-00. Additional information was also provided by emails dated July 7 and July 14, 2026. The Tubing Set is designed exclusively for use with the Cool Point™ Irrigation Pump, which is not imported with the set. Together, they provide a sterile pathway for delivering irrigation solutions to a catheter tip during cardiac ablation procedures. The Pump uses a peristaltic mechanism to control liquid flow, while the Tubing Set delivers the solution and stops the flow if a blockage is detected. The Tubing Set is a sterile, single-use medical device designed solely for use with the Cool Point™ Irrigation Pump, with no independent commercial function. It consists of PVC tubing (U.S. origin) that forms the sterile fluid pathway, a pressure sensor (U.S. origin) for monitoring fluid pressure and detecting abnormalities, a drip chamber (China origin) for visual flow indication and air prevention, an electrical cable (China origin) for transmitting sensor signals to the pump, a stopcock (Israel origin) for manual fluid control, and various connectors of U.S. origin that securely join tubing segments and components. You describe the manufacturing process as follows: The U.S.-origin sensing die is manufactured in wafer form at a wafer fabrication facility in the United States, where it undergoes etching, processing, and qualification to meet performance specifications. After electrical testing, the wafer is shipped to China for further assembly. The U.S.-origin PVC tubing is produced by a U.S. vendor, cut to specified lengths, and exported to China.

In China, the sensing die is mounted onto a ceramic substrate, integrated into a protective housing, and electrically connected to a cable assembly. Final assembly of the Tubing Set includes bonding the pressure sensor to U.S.-origin PVC tubing segments, a Chinese-origin drip chamber, and an Israeli-origin stopcock, as well as mechanically joining connectors and adhesive bonding of components. The completed package is sterilized prior to importation into the United States. As noted in your email, U.S.-origin costs account for 53% of the total cost of materials. When determining the country of origin for purposes of applying ordinary most favored nation duties, current trade remedies under Section 301, and additional duties, 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). In this case, the assembly process performed in China - including mounting the sensing die, connecting the electrical cables, bonding the PVC tubing, drip chamber, and stopcock, and mechanically joining the connectors - is not significantly complex to transform the U.S. components into new and different articles of commerce and does not result in a substantial transformation. In our opinion, the critical function of the tubing set is imparted by the U.S. components, specifically the PVC tubing and pressure sensor, as they provide the sterile pathway for the safe delivery of irrigation solution and monitor fluid pressure within the tubing system, respectively. Additionally, the cost of the U.S. components accounts for more than half of the total material cost. Therefore, the country of origin of the single-use medical tubing set, part number 20034352-00, is the United States. 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 Dionisia Melman at [email protected].
Sincerely,
(for) James P. Forkan Director National Commodity Specialist Division