OT:RR:CTF:EMAIN H343563 MFT
Bryan G. Wixted, CEO DMC
Medical Ltd.
Unit 5, Abbey House
Shannon Town, Co. Clare V14 AH61
Ireland
Re: Request for Reconsideration of NY N341133; Classification of Syringes from China
Dear Mr. Wixted,
This letter is in response to your request for the reconsideration of New York Ruling
Letter (NY) N341133, dated July 15, 2024, in which U.S. Customs and Border Protection (CBP)
issued a binding ruling regarding the classification of certain syringes from China under the
Harmonized Tariff Schedule of the United States (HTSUS). For the reasons set forth below, we
affirm our conclusion therein.
NY N341133 describes the subject merchandise as follows:
The items under consideration are described as DMC Medical Polycarbonate Syringes
and DMC Medical NuGen™ Eastman Tritan ™ Copolyester
Syringes. Both types of syringes consist of a calibrated barrel, a color ABS plunger,
a silicone stopper, and a male luer lock and are available in 1ml, 3ml, 6ml, 10ml,
20ml and 30ml sizes. The syringes will be imported in bulk in non-sterile form.
They will undergo sterilization and further packaging into surgical kits in the United
States before entering the market. The syringes are intended to be used without a
needle for administering various drugs and contrast medium during medical
procedures.
The ruling held that both types of syringes are classified as “[s]yringes [. . .] without needles” of
subheading 9018.31, HTSUS. You dispute this finding in your letter requesting reconsideration of
NY N341133, stating:
Our syringes are well outside the scope of 9018.31 and should be classified as such.
They form an integral part of a cardiovascular surgical kit. [. . .] We would regard
these syringes more so as a “component” within a surgical kit than a basic syringe,
such as the mass[-]produced hypodermic syringes out of China.
DMC’s custom colored polycarbonate syringes (high pressure) are included in
surgical procedure trays for cardiovascular (Angiography & Angioplasty) and used
to administer “Contrast/drugs” by the practitioner. These syringes are an integral
component within the surgical procedure tray and should be treated as such. [. . .]
You note that the “[i]ntended purpose of the surgical kits” which incorporate the subject syringes
is for use “in a hospital setting by trained medical professionals on patients undergoing
interventional radiology or angiography procedures, which includes the general patient
population. The kits/product are designed to be used for the intra-arterial or intravenous
administration of radiographic contrast media.” You further clarified that the syringes are
imported alone, repackaged for use into custom kits post-importation, and that sterilization of the
syringes is the only additional process required to form a “finished” syringe.
The issue here is whether the subject syringes are classifiable under subheading 9018.31,
HTSUS, as “syringes [. . .] without needles.” Classification under the HTSUS is in accordance
with the General Rules of Interpretation (GRIs). GRI 1 provides that the classification of goods
will be determined according to the terms of the headings of the tariff schedule and any relative
section or chapter notes. In the event that the goods cannot be classified solely on the basis of
GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs 2
through 6 will then be applied in order.
GRI 6 states that for legal purposes, the classification of goods in the subheadings of a
heading shall be determined according to the terms of those subheadings and any related
Subheading Notes and, mutatis mutandis, to GRIs 1 through 5, on the understanding that only
subheadings at the same level are comparable. For the purposes of GRI 6, the relative Section
and Chapter Notes also apply, unless the context otherwise requires.
The HTSUS heading and subheading under consideration are as follows:
9018 Instruments and appliances used in medical, surgical, dental or veterinary
sciences, including scintigraphic apparatus, other electromedical apparatus
and sight-testing instruments; parts and accessories thereof:
Syringes, needles, catheters, cannulae and the like; parts and
accessories thereof:
9018.31 Syringes, with or without needles; parts and
accessories thereof
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There is no dispute that the subject merchandise constitutes “[i]nstruments [. . .] used in
medical sciences” under heading 9018, HTSUS. Under GRIs 1 and 6, to be classifiable under
subheading 9018.31, HTSUS, the articles at issue must meet the relevant terms of that provision:
to wit, “[s]yringes, with or without needles.” The subject merchandise undeniably constitutes
“syringes.” Both the polycarbonate and copolyester syringes under consideration contain
components necessary to form the essential character of “syringes” under subheading 9018.31,
HTSUS, such as barrels, plungers, stoppers, and luer locks. Because the subheading text is
unambiguously noncontingent on the incorporation of needles in the syringes, the fact that these
syringes are intended for use without needles is immaterial. Given these facts, NY N341133
appropriately classified the subject syringes under subheading 9018.31, HTSUS.
You claim that the syringes are not “finished” syringes without sterilization
postimportation, but nowhere in the legal text does subheading 9018.31, HTSUS, require
sterilization. That the syringes may eventually be incorporated into surgical kits post-importation
is likewise unpersuasive. Merchandise must be classified according to its condition as imported.
See Mita Copystar America v. United States, 21 F.3d 1079, 1082–83 (Fed. Cir. 1994). As the
Court of Appeals for the Federal Circuit recognized:
If the rule were otherwise, not only could the same product be subject to different
duty rates depending on its intended end use, but Customs would be flooded with
affidavits or other evidence of differing intended uses. Moreover, Customs would
have no way of determining whether the merchandise was actually used for its
alleged intended purpose after importation.
Id. at 1082. As the syringes are imported alone, and not together with the rest of the surgical kit,
we must classify them as syringes.
By application of GRIs 1 and 6, the subject syringes are classified under heading 9018,
HTSUS, specifically subheading 9018.31.00, HTSUS, which provides for, “Instruments 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: Syringes, needles, catheters, cannulae and the like; parts and accessories thereof:
Syringes, with or without needles; parts and accessories thereof.” The general column one rate of
duty is free.
Accordingly, NY N341133, dated July 15, 2024, is hereby AFFIRMED.
Sincerely,
Yuliya A. Gulis, Director
Commercial and Trade Facilitation Division
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