CLA-2-90:OT:RR:NC:N3: 135
Deanna Gresens
Transmodal Corporation
545 Island Road
Ramsey, NJ 07446
RE: The classification of a lancing device and lancets from China
Dear Ms. Gresens:
In your letter dated May 14, 2025, you requested a tariff classification ruling on behalf of Ascensia Diabetes
Care Holdings AG. During a phone call on June 10, 2025, you clarified that your request included the
Microlet Next 2 Lancing Device and Microlet Next Lancets.
Microlet Next Lancets are disposable blood lancets used with the Microlet family of lancing devices. Each
blood lancet is composed of a stainless steel 28-gauge needle coated with silicone oil on the tip, a plastic cap,
and a plastic holder. One hundred pieces of the lancets are packaged in a box for retail sale. The Microlet
Next 2 Lancing Device is a non-sterile, multiple use pen-like device for a single patient featuring a lancet
ejector and a flexible vibration damping component. The lancing device has a removable black endcap
having nine puncture depth settings for fingertip testing. It also has a clear non-adjustable endcap with a fixed
puncture depth for palm alternative site testing. A lancet will be inserted in the lancing device and when
activated, the lancing device propels the lancet into the skin to obtain a blood sample for testing.
The applicable subheading for the Microlet Next Lancets will be 9018.39.0050, HTSUS, which provides for
“[i]nstruments 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:
[s]yringes, needles, catheters, cannulae and the like; parts and accessories thereof: [o]ther: [o]ther.” The
general rate of duty will be free.
The applicable subheading for the Microlet Next 2 Lancing Device will be 9018.90.8000, Harmonized Tariff
Schedule of the United States (HTSUS), which provides for “[i]nstruments and appliances used in medical,
surgical, dental or veterinary sciences … parts and accessories thereof: [o]ther instruments and appliances
and parts and accessories thereof: [o]ther: [o]ther.” 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 9018.39.0050 or 9018.90.8000 . 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
9018.39.0050 or 9018.90.8000 , HTSUS, listed above.
However, the additional duties imposed by subheadings 9903.01.24 or 9903.01.25 shall not apply to goods
for which entry is properly claimed under a provision of chapter 98 of the tariff schedule pursuant to
applicable regulations of U.S. Customs and Border Protection (“CBP”), and whenever CBP agrees that entry
under such a provision is appropriate, except for goods entered under heading 9802.00.80; and subheadings
9802.00.40, 9802.00.50, and 9802.00.60.
In your submission you requested consideration of a secondary classification under 9817.00.96, HTSUS,
which applies to articles and parts and accessories of articles specifically designed or adapted for the use or
benefit of the permanently or chronically physically or mentally handicapped.
Subheading 9817.00.96, HTSUS, covers: “[a]rticles specially designed or adapted for the use or benefit of the
blind or other physically or mentally handicapped persons; parts and accessories (except parts and
accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the
foregoing articles: [o]ther.” The term “blind or other physically or mentally handicapped persons” includes
“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.” U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS.
Subheading 9817.00.60, HTSUS, excludes “(i) articles for acute or transient disability; (ii) spectacles,
dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic
articles; or, (iv) medicine or drugs.” U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS.
In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (Ct. Int’l Trade 2017), aff’d, 899 F.3d 1308
(Fed. Cir. 2018), the U.S. Court of International Trade (CIT) explained that “specially” means “to an extent
greater than in other cases or towards others” and “designed” means something that is “done, performed, or
made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” We
must first evaluate “for whose, if anyone’s, use and benefit is the article specially designed,” and then,
whether “those persons [are] physically handicapped ”. Sigvaris, 899 F.3d at 1314.
The Court of Appeals for the Federal Circuit (CAFC) clarified in Sigvaris, 899 F.3d at 1314-15 that to be
“specially designed,” the merchandise “must be intended for the use or benefit of a specific class of persons
to an extent greater than for the use or benefit of others” and adopted the five factors used by U.S. Customs
and Border Protection (CBP):
(1) the physical properties of the article itself (i.e., whether the article is easily distinguishable by properties
of the design, form, and the corresponding use specific to this unique design, from articles useful to
non-handicapped persons); (2) whether any characteristics are present that create a substantial probability of
use by the chronically handicapped so that the article is easily distinguishable from articles useful to the
general public and any use thereof by the general public is so improbable that it would be fugitive; (3)
whether articles are imported by manufacturers or distributors recognized or proven to be involved in this
class or kind of articles for the handicapped; (4) whether the articles are sold in specialty stores which serve
handicapped individuals; and, (5) whether the condition of the articles at the time of importation indicates
that these articles are for the handicapped.
We note that CBP has consistently ruled that persons with diabetes are considered physically handicapped
within the meaning of U.S. Note 4(a). See e.g., HQ 964169, dated June 26, 2001, HQ 561283, dated August
26, 1999, and HQ 561020 dated October 14, 1998. CBP has previously ruled that diabetic pen needles and
lancets (HQ H110795, dated August 5, 2011), glucose test strips for glucose test meters (HQ H039775, dated
April 17, 2009), glucose monitoring systems (NY ruling N341988, dated August 15, 2024), and carrying
cases specifically designed to hold and carry blood glucose meters (HQ 563264, dated May 6, 2005),
qualified for duty-free treatment under subheading 9817.00.96, HTSUS. The Microlet Next Lancets and
Microlet Next 2 Lancing Device are designed to be used together to obtain a diabetic’s blood sample to be
analyzed by a blood glucose monitoring device. They are crucial tools for individuals with diabetes, enabling
them to monitor their blood sugar levels regularly. Based on the precedents, they qualify for duty-free
treatment under subheading 9817.00.96, HTSUS.
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 Fei Chen at [email protected].
Sincerely,
(for)
Steven A. Mack
Director
National Commodity Specialist Division