CLA-2-90:OT:RR:NC:N1:105
Matthew Pfeifer
iHealth Labs
880 W Maude Avenue
Sunnyvale, CA 94085
RE: The tariff classification of blood glucose monitoring system from China
Dear Mr. Pfeifer:
In your letter dated June 18, 2025, you requested a tariff classification ruling. Descriptive literature was
provided for our review.
The item under consideration is the iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+),
which is a device that allows users to measure and track their blood glucose levels using a smartphone or
tablet. It connects via Bluetooth and automatically records readings in the iGluco app, eliminating the need
for manual logging. The system simplifies blood sugar management by providing a connected way to
monitor, store, and share data with healthcare providers or family members. The system includes the iHealth
Wireless Smart Glucose Meter, iHealth Glucose Test Strips (EGS-2003), and the iHealth Gluco-Smart App
(mobile application).
This system is designed for use by individuals with diabetes to self-monitor blood glucose levels. It utilizes
an electrochemical measurement method, wherein a drop of fresh capillary whole blood is applied to the test
strip, which reacts with glucose dehydrogenase. This reaction generates a small electric current that is
measured by the glucose meter to determine the glucose concentration. The accompanying mobile
application provides real-time tracking and data analysis for ongoing diabetes management. The system can
measure blood samples drawn from various body sites, including the fingertip, palm, forearm, upper arm,
calf, or thigh, making it adaptable and convenient for users with mobility or dexterity challenges.
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 part only 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
iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) is imparted by the glucose meter.
The applicable subheading for the iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) is
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 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 20 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 9027.89.4530, 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 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.
Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under
subheading 9027.89.4530, 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 9027.89.4530, 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 iHealth Wireless
Smart Gluco-Monitoring System 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 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 Headquarters ruling 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 iHealth Wireless Smart
Gluco-Monitoring System performs 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 iHealth Wireless
Smart Gluco-Monitoring System is specifically designed for use by the handicapped for secondary
classification purposes. In our view, the iHealth Wireless Smart Gluco-Monitoring System 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 iHealth Wireless Smart Gluco-Monitoring System 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.
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