CLA-2-90:OT:RR:NC:N1:105

Samuel Finkelstein
LMD Trade Law PLLC
1629 K Street NW, Suite 300
Washington, DC 20006

RE: The tariff classification of blood glucose monitoring systems from Vietnam

Dear Mr. Finkelstein:

In your letter dated July 1, 2025, on behalf of your client, AgaMatrix, Inc., you requested a tariff classification ruling. Descriptive literature was provided for our review.

The items under consideration are described as blood glucose monitoring kits identified as the AgaMatrix Presto System Kit (part number 8000-02649), the AgaMatrix Jazz Wireless 2 System Kit (part number 8000-10471), and the Health All-In-One System Kit (part number 8000-10933). Each kit operates in a substantially similar way and are only differentiated by size, shape, and a few additional features (such as Bluetooth connectivity). Each meter kit is shipped with the meter, carrying case, owner’s guide, test strips, lancing device, and lancets.

In operation, a small blood sample is applied to a test strip before inserting into the meter. The meter then uses a chemical reaction on the test strip to determine the glucose concentration in the blood sample. The test strip contains a biosensor that reacts with the glucose in the blood, and the meter measures the resulting electrical current. The meter then displays the blood glucose reading on its screen. If the specific model has Bluetooth capabilities, and it is enabled and paired with a compatible app, the meter automatically transmits the glucose reading to the app. The meters are designed to help individuals with diabetes manage their blood glucose levels.

General Rule of Interpretation (GRI) 1, Harmonized Tariff Schedule of the United States (HTSUS), states in part that for legal purposes, classification shall be determined according to the terms of the headings and any relative section or chapter notes. Goods that are, prima facie, classifiable under two or more headings, are classifiable in accordance with GRI 3, HTSUS. GRI 3(a) states, in part, that when two or more headings each refer to a part of the items in a set put up for retail sale, those headings are to be regarded as equally specific, even if one heading gives a more precise description of the good. The instant goods consist of at least two different articles that are, prima facie, classifiable in different subheadings. It consists of articles put up together to carry out a specific activity (i.e., blood glucose testing). Finally, the articles are put up in a manner suitable for sale directly to users without repacking. Therefore, the goods in question are within the term “goods put up in sets for retail sale.” GRI 3(b) states, in part, that goods put up in sets for retail sale, which cannot be classified by reference to GRI 3(a), are to be classified as if they consisted of the component which gives them their essential character. It is the opinion of this office that the essential character of the glucose meter kits when imported with the meter, carrying case, owner’s guide, test strips, lancing device, and lancets, is imparted by the glucose meter.

As you suggest in your letter, the applicable subheading for the AgaMatrix Presto System Kit (part number 8000-02649), the AgaMatrix Jazz Wireless 2 System Kit (part number 8000-10471), and the Health All-In-One System Kit (part number 8000-10933) will be 9027.89.4530, 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.” The general rate of duty will be free.

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 from all countries will be subject to an additional 10 percent ad valorem rate of duty. 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 9027.89.4530, HTSUS, listed above.

In your letter, you also requested consideration of a secondary classification for the subject blood glucose meter kits under 9817.00.96, HTSUS, which applies to articles and parts of articles specifically designed or adapted for the use or benefit of the permanently or chronically physically or mentally handicapped. 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 oneself, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working.”

We note that in Headquarters Ruling (HQ) 561020 (dated October 14, 1998), 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 for secondary classification purposes. In New York Ruling 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 blood glucose meters perform a chemical analysis on a diabetic’s blood sample 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 that the AgaMatrix Presto System Kit, the AgaMatrix Jazz Wireless 2 System Kit, and the Health All-In-One System Kit are specifically designed for use by the handicapped for secondary classification purposes. In our view, the subject blood glucose meters satisfy 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 AgaMatrix Presto System Kit, the AgaMatrix Jazz Wireless 2 System Kit, and the Health All-In-One System Kit 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 heading 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 [email protected].
Sincerely,

(for)
James Forkan
Acting Director
National Commodity Specialist Division