RE: The tariff classification of a high-pressure syringe set from Malaysia

U.S. Department of Homeland Security U.S. Customs and Border Protection National Commodity Specialist Division One World Trade Center, Suite 51.201 New York, NY 10007 U.S. Customs and Border Protection N365408 October 22, 2026 CLA-2-90:OT:RR:NC:N3: 143 CATEGORY: Classification, Origin, Marking TARIFF NO.: 9018.31.0080 Lau Chin Antmed Malaysia Sdn Bhd Lot 8322, Lot 8322, Persiaran Springhill, Pork Dickson, Negeri Sembilan Springhill 71010 Malaysia RE: The tariff classification of a high-pressure syringe set from Malaysia Dear Ms. Chin: In your letter dated September 25, 2026, you requested a tariff classification ruling. Additional information was provided via email. The imported product is a high-pressure syringe set, model REF 200111.The complete syringe set is housed in a blister tray, which consists of a barrel, a plunger assembly, a coiled tube, a fill tube, a long spike and dust caps. The high-pressure syringe is intended to be used with a contrast media injector to deliver contrast media and/or saline within the area of Computed Tomography (CT), Magnetic Resonance Imaging (MRI) and Digital Subtraction Angiography (DSA). As you state, the high-pressure syringe is for single use only. Additionally, it is intended for use by trained healthcare professionals including physicians, radiologists, nurses, and other qualified medical personnel, in hospitals, diagnostic imaging centers and other healthcare facilities. The applicable subheading for the a high-pressure syringe set, model REF 200111, when imported into the United States, will be 9018.31.0080, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof: Syringes, needles, catheters, cannulae and the like; parts and accessories thereof: Syringes, with or without their needles: Other.” The general rate of duty will be Free. As you indicate, all raw materials, including plastic resin and color masterbatch, are imported from China. In Malaysia, these raw materials are processed to manufacture the individual components and then subsequently assembled into the finished high-pressure syringe product. Manufacturing and processing operations performed in Malaysia include raw-material preparation; extrusion tube forming and processing; injection molding of raw materials into high-pressure syringe components, including barrels, plungers, protective caps, connectors, long spikes, and dust caps; component assembly; adhesive bonding; printing; inspection; blister packaging and sealing; ethylene oxide sterilization; aeration; finished-product inspection; and storage and preparation for shipment. When determining the country of origin, the substantial transformation analysis is applicable. See, e.g., Headquarters Ruling Letter (“HQ”) 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). Additionally, 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. Friedlaender & 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. This office has reviewed the provided manufacturing operations and is of the opinion that the Chinese raw materials undergo sufficiently complex and meaningful processing in Malaysia to result in a substantial transformation. Specifically, the raw materials lose their individual identities and become a new article with a new name, character, and use. Accordingly, we find that the country of origin of the high-pressure syringe set is Malaysia for marking purposes and the assessment of duty rates. The duties cited above are current as of this ruling’s issuance. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided at https://hts.usitc.gov/. This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or other charges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and other duties as provided for in Subchapter III to Chapter 99, HTSUS. Thus, for example, in addition to the classification stated above, the merchandise covered by this ruling may also need to be reported with either the Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisions covering exceptions to such tariffs. For further information to assist with the importation process, please refer to the frequently updated Cargo Systems Messaging Service (CSMS) messages at https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and the Trade Remedies page at https://www.cbp.gov/trade/programs-administration/trade-remedies. 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 dionisia.y.melman@cbp.dhs.gov. Sincerely, (for) James P. Forkan Director National Commodity Specialist Division