The tariff classification of a continuous glucose monitor from China

N355538 November 25, 2025 CLA-2-90:OT:RR:NC:CEE010:N1:105 CATEGORY: Classification TARIFF NO.: 9027.50.4060; 9903.01.24; 9903.01.25; 9903.88.01; 9817.00.96 Schalal Habib KOS 950 Page Mill Road, Suite 104 Palo Alto, CA 94304 RE: The tariff classification of a continuous glucose monitor from China Dear Mr. Habib: In your letter dated October 30, 2025, you requested a tariff classification ruling. Descriptive literature was provided for our review. The item under consideration is described as the KOS Argus Non-Invasive Continuous Glucose Monitor (CGM), which is a prescription, non-invasive device used to continuously measure, record, analyze, and display real-time glucose values using infrared, red, and green sensors. The tri-wavelength optical system interrogates different tissue compartments. The green-light spectrum penetrates the epidermis, capturing superficial capillary bed dynamics. The red-light spectrum reaches the dermis layer, monitoring intermediate vascular networks. Finally, the near-infrared spectrum penetrates to the hypodermis, assessing deep tissue perfusion. This multi-layer approach provides a comprehensive view of tissue hemodynamics, enabling the system to differentiate glucose-induced changes from other physiological variations. The wearable device uses a custom non-invasive multi-wavelength sensor board with high-efficiency LEDs coupled with a medical grade analogue front-end (AFE) and weighs 4,050 grams. The components consist of a sensor unit, a rechargeable battery bank that connects to the sensor unit magnetically, and a base station to charge the battery bank. The device is intended for use in the management of Type 1 and Type 2 Diabetes Mellitus, as well as for Pre-Diabetes patients. The device will be used for real-time monitoring of glucose levels in clinical and home settings. In your letter, you suggest the applicable subheading for the KOS Argus Non-Invasive Continuous Glucose Monitor to be 9027.89.4530, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Instruments and apparatus for physical or chemical analysis (for example, polarimeters, refractometers, spectrometers, gas or smoke analysis apparatus); instruments and apparatus for measuring or checking viscosity, porosity, expansion, surface tension or the like; instruments and apparatus for measuring or checking quantities of heat, sound or light (including exposure meters); microtomes; parts and accessories thereof: Other instruments and apparatus: Other: Other: Electrical: Chemical analysis instruments and apparatus.” We disagree. While the CGM will be classified within heading 9027, HTSUS, the device utilizes an optical element to perform the analysis instead of a chemical analysis. Since the analyzers utilize an optical component, subheading 9027.89, HTSUS, would not apply. Accordingly, the applicable subheading for the KOS Argus Non-Invasive Continuous Glucose Monitor is 9027.50.4060, HTSUS, which provides for “Instruments and apparatus for physical or chemical analysis (for example, polarimeters, refractometers, spectrometers, gas or smoke analysis apparatus); instruments and apparatus for measuring or checking viscosity, porosity, expansion, surface tension or the like; instruments and apparatus for measuring or checking quantities of heat, sound or light (including exposure meters); microtomes; parts and accessories thereof: Other instruments and apparatus using optical radiations (ultraviolet, visible, infrared): Other: Electrical: Other.” The general rate of duty will be free. Effective March 4, 2025, pursuant to U.S. Note 2(u) to Subchapter III, Chapter 99, all products of China and Hong Kong as provided by heading 9903.01.24, HTSUS, other than products classifiable under headings 9903.01.21, 9903.01.22, and 9903.01.23, HTSUS, will be subject to an additional 10 percent ad valorem rate of duty. At the time of entry, you must report the applicable Chapter 99 heading, i.e. 9903.01.24, in addition to subheading 9027.50.4060, HTSUS, listed above. Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise must be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of the Chapter 99 provisions covering exceptions to the reciprocal tariffs. At this time, products of China, Hong Kong, and Macau will be subject to an additional ad valorem rate of duty of 10 percent. At the time of entry, you must report the Chapter 99 heading applicable to your product classification, i.e. 9903.01.25, in addition to subheading 9027.50.4060, HTSUS, listed above. Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under subheading 9027.50.4060, HTSUS, unless specifically excluded, are subject to an additional 25 percent ad valorem rate of duty. At the time of importation, you must report the Chapter 99 subheading, i.e., 9903.88.01, in addition to subheading 9027.50.4060, HTSUS, listed above. The HTSUS is subject to periodic amendment so you should exercise reasonable care in monitoring the status of goods covered by the Note cited above and the applicable Chapter 99 subheading. For background information regarding the trade remedy initiated pursuant to Section 301 of the Trade Act of 1974, you may refer to the relevant parts of the USTR and CBP websites, which are available at https://ustr.gov/issue-areas/enforcement/section-301-investigations/tariff-actions and https://www.cbp.gov/trade/remedies/301-certain-products-china respectively. In your letter, you also requested consideration of a secondary classification for the subject KOS Argus Non-Invasive Continuous Glucose Monitor under 9817.00.96, HTSUS, which applies to articles and parts of articles specifically designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons. Chapter 98, Subchapter XVII, U.S. Note 4(a), HTSUS, defines the term blind or other physically or mentally handicapped persons as including “any person suffering from a permanent or chronic physical or mental impairment which substantially limits one or more major life activities, such as caring for one’s self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working.” We note that in Headquarters Ruling (HQ) 561020, dated October 14, 1998, U.S. Customs and Border Protection (CBP) held that people with diabetes suffer from a permanent or physical impairment within the meaning of U.S. Note 4(a) to Chapter 98 of the HTSUS. In HQ 562869, dated December 23, 2003, CBP held that a pump designed for individuals suffering from diabetes or glucose control problems was an article specifically designed or adapted for the handicapped and is properly classified under 9817.00.96, HTSUS, for secondary classification purposes. In New York Ruling Letter (NY) N292225, dated December 18, 2017, CBP held that Insulet’s Insulin Delivery Omnipod was classified under 9817.00.96 for secondary classification purposes. Additionally, as discussed in HQ 964169, dated June 26, 2001, “people with diabetes are limited in their ability to perform a broad range of jobs because they must be able to monitor their blood sugar, inject insulin if prescribed, and have work restrictions due to excessive urination, possible nausea, dizziness and fainting. This interferes with working, a major life activity. Therefore, persons with diabetes suffer from a permanent or chronic physical impairment which substantially limits a major life activity and therefore, are considered physically handicapped persons under U.S. Note 4(a).” The KOS Argus Non-Invasive Continuous Glucose Monitor performs an optical analysis on a diabetic’s wrist to determine if their levels are too high or too low, which is a direct link to the physical impairment. Accordingly, based on the information provided, it is the opinion of this office the KOS Argus Non-Invasive Continuous Glucose Monitor is specifically designed for use by the handicapped for secondary classification purposes. In our view, the KOS Argus Non-Invasive CGM satisfies the description set forth in Chapter 98, Subchapter XVII, U.S. Note 4(a). Therefore, we agree that secondary classification 9817.00.96, HTSUS, would apply to the KOS Argus Non-Invasive CGM and will be free of duty and the Merchandise Processing Fee (MPF) upon importation into the United States. Please note that the additional duties imposed by headings 9903.88.01, 9903.01.24, and 9903.01.25 do not apply to goods for which entry is properly claimed under a provision of chapter 98 of the HTSUS, except for goods entered under headings 9802.00.40, 9802.00.50, 9802.00.60, and 9802.00.80. For headings 9802.00.40, 9802.00.50, and 9802.00.60, the additional duties apply to the value of repairs, alterations, or processing performed abroad, as described in the applicable heading. For heading 9802.00.80, the additional duties apply to the value of the article less the cost or value of such products of the United States, as described in heading 9802.00.80. The tariffs and additional 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/. 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