The country of origin of Disposable Ag/AgCl Cup electrodes

N356289 December 17, 2025 OT:RR:NC:N3:135 CATEGORY: Origin George Tuttle, III Tuttle Law Offices 3950 Civic Center Drive, Suite 105 San Rafael, CA 94903 RE: The country of origin of Disposable Ag/AgCl Cup electrodes Dear Mr. Tuttle: In your letter dated November 20, 2025, you requested a country of origin ruling on Disposable Ag/AgCl Cup electrodes on behalf of your client, Technomed USA, Inc. The merchandise at issue is Technomed’s Disposable Ag/AgCl cup electrode, a single-use medical device used to measure bioelectrical signals from the body, typically in clinical and research settings. Common applications include monitoring electroencephalography (EEG), Polysomnography (PSG), and Evoked Potentials (EP). They are called “cup” electrodes because of their small concave shape that holds a bit of conductive gel or paste (applied at use), ensuring good skin contact and signal conduction. The Ag/AgCl material provides a stable and low-noise electrical interface between the skin and recording equipment. The disposable nature of the electrode simplifies application, maintains consistent signal quality, and the risk of cross-contamination. There are five components of the electrode: 1. Ag/AgCl cup – a non-polarized sensor made of 20% glass-filled ABS plastic, and plated with either silver (Ag) or chloritized with Silver Chloride (AgCl). It is made in the Unites States. 1. Crimp tube – made of tin (Sn) plated copper (Cu)-a metal sleeve crimped to the end of stranded wire to prevent fraying and provide the electrical connection. It is made in the Netherlands. 1. Heat shrink tubing – a plastic sleeve which when heated, shrinks tightly around the wire providing isolation and protection. It is made in China. 1. Lead wires – Tin-plated copper wires coated with PVC 85A sheathing to provide electrical conductivity from the Ag/AgCl cup to the connector. It is made in South Korea. 1. 1. Connector – 0.5 mm connector socket (compatible with EEG systems) designed in accordance with EC53:2013 / DIN 42802 standards, featuring an overmolded construction made from medical-grade PVC with a hardness rating of 85A. It is made in South Korea. The assembly of the Disposable Ag/AgCl cup electrode occurs both in South Korea and Indonesia. In South Korea, the lead wire and the DIN 42802 connector are overmolded together through injection molding. The lead wire and connector assembly is then sent to Indonesia for further processing. In Indonesia, a piece of shrink tubing is first slid onto the lead wire far enough to leave the stripped section uncovered. A crimp tube is slid over the stripped end of the wire until it reaches the insulation. Next, the stem of the U.S.-origin Ag/AgCl cup is inserted into the crimp tube until it contacts the lead wire. The subassembly is then placed in the lower crimp die with the cup positioned securely in the cup holder. The crimping tool's handle is pushed down all the way, crimping the ferrule bootlace. This action permanently joins the lead wire to the Ag/AgCl cup. Then, the shrink tube is attached over the ferrule bootlace by heat shrinking. After that, the product is inspected, cleaned, and packaged. Section 304 of the Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that unless excepted, every article of foreign origin imported into the United States shall be marked in a conspicuous place as legibly, indelibly, and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the United States, the English name of the country of origin of the article. Congressional intent in enacting 19 U.S.C. 1304 was “that the ultimate purchaser should be able to know by an inspection of the marking on the imported goods the country of which the goods is the product. The evident purpose is to mark the goods so that at the time of purchase the ultimate purchaser may, by knowing where the goods were produced, be able to buy or refuse to buy them, if such marking should influence his will.” See United States v. Friedlander & Co., 27 C.C.P.A. 297, 302 (1940). Part 134 of the U.S. Customs and Border Protection (“CBP”) Regulations (19 CFR 134) implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304. Section 134.1(b), CBP Regulations (19 CFR 134.1(b)), defines “country of origin” as the country of manufacture, production, or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the “country of origin” within the meaning of the marking laws and regulations. A substantial transformation occurs when, as a result of manufacturing process, a new and different article emerges, having a distinct name, character or use, which is different from that originally possessed by the article or material before being subjected to the manufacturing process. See United States v. Gibson-Thomsen Co., Inc., 27 C.C.P.A. 267 (C.A.D. 98) (1940) and 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). The operations performed in Indonesia, including crimping the lead wire to the cup, heat-shrinking the tube, inspecting, cleaning, and packaging, are considered simple and minor processes. These steps do not substantially transform the imported components. The essence of the product is imparted by the Ag/AgCl cup, which allows for a physical connection between a patient and the medical diagnostic equipment when the electrode is applied directly to a patient’s skin to record physiological signals. Since the U.S.-made Ag/AgCl cup doesn't change its nature, name, or use after being processed in Indonesia, the country of origin of the Technomed’s finished disposable cup electrodes will be the United States for origin and marking purposes at the time of importation into the United States. It may be excepted from country of origin marking when imported into the United States, pursuant to 19 CFR 134.32(m). Whether the disposable cup electrodes can be marked as “Made in the U.S.” or reference to U.S. content is a matter within the jurisdiction of the Federal Trade Commission (FTC) and we suggest that you contact that agency for a determination. 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 Fei Chen at fei.chen@cbp.dhs.gov. Sincerely, (for) Evan Conceicao Designated Official Performing the Duties of the Division Director National Commodity Specialist Division