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 kits from South Korea
Dear Mr. Finkelstein:
In your letter dated July 14, 2025, on behalf of your client, i-SENS USA, 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 CareSens N
Blood Glucose Monitoring Starter Kit (part number 164307), the CareSens N Plus BT Blood Glucose
Monitoring Starter Kit (part number 164372), the CareSens N Feliz Blood Glucose Monitoring Starter Kit
(part number 164507), the Blood Glucose Monitoring Starter Kit (part number TE-KBGZ-A1), and the Blood
Glucose Monitoring Kit (part number 343262). The glucose monitors are all very similar with only a small
change in shape and size, and a few additional features such as Bluetooth connectivity. The blood glucose
monitors operate by using a disposable blood glucose test strip which is inserted into the blood glucose
monitor. After inserting the test strip, the user applies a small sample of blood obtained using a lancing
device to the test strip, which produces an electrochemical signal in proportion to the glucose concentration
in the blood sample. The meters measure this signal using dynamic electrochemistry to measure blood
glucose levels and correct for common analytical interferents such as hematocrit. The results are displayed on
the attached screen or via Bluetooth on capable devices.
The blood glucose monitoring kits contain a standard set of components, which includes a blood glucose
monitor (a device used by persons afflicted with diabetes to measure the glucose levels in blood), a carrying
case (a protective container designed to carry and store diabetes supplies), an owner’s guide (instructions for
use), lancets (disposable devices used to prick the skin to obtain a blood sample, lancing device (tool that
uses a lancet to puncture the skin to obtain the blood sample), and two CR2032 batteries (power the blood
glucose monitor).
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
blood glucose monitoring kits is imparted by the blood glucose monitor.
The applicable subheading for the CareSens N Blood Glucose Monitoring Starter Kit (part number 164307),
the CareSens N Plus BT Blood Glucose Monitoring Starter Kit (part number 164372), the CareSens N Feliz
Blood Glucose Monitoring Starter Kit (part number 164507), the Blood Glucose Monitoring Starter Kit (part
number TE-KBGZ-A1), and the Blood Glucose Monitoring Kit (part number 343262) 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
monitoring 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 monitors 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 CareSens N Blood
Glucose Monitoring Starter Kit, the CareSens N Plus BT Blood Glucose Monitoring Starter Kit, the CareSens
N Feliz Blood Glucose Monitoring Starter Kit, and both versions of the Blood Glucose Monitoring Starter
Kit are specifically designed for use by the handicapped for secondary classification purposes. In our view,
the subject blood glucose monitoring kits 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
CareSens N Blood Glucose Monitoring Starter Kit, the CareSens N Plus BT Blood Glucose Monitoring
Starter Kit, the CareSens N Feliz Blood Glucose Monitoring Starter Kit, and both versions of the Blood
Glucose Monitoring Starter 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