CLA-2-90:OT:RR:NC:N3:135
Thomas Helms
Pursuant Health
817 W Peachtree St. NE, STE M-105
Atlanta, GA 30308
RE: The tariff classification of a retinal imaging instrument from Taiwan
Dear Mr. Helms:
In your letter dated August 14, 2025, you requested a tariff classification ruling.
The merchandise under consideration is a fully assembled retinal imaging instrument. It is a complete,
standalone ophthalmic diagnostic device designed to capture high-resolution images of the human retina for
use in medical screenings and examinations. It consists of an outer housing (made of an aluminum alloy with
plastic components), an optical system (lenses, mirrors, and optical sensors for retinal imaging),
optomechanics (3 axis motorized optical bench), electronics (circuit boards, imaging sensor array,
display/control interfaces, and microcontroller), and embedded software. The principle use of the device is
non-invasive medical imaging of the retina to assist in diagnosis and monitoring of eye diseases such as
diabetic retinopathy, macular degeneration, and glaucoma. Upon import, you state the instrument is fully
functional and capable of performing retinal imaging independently. When powered, the device captures
high-resolution retinal images for subsequent review by a healthcare provider. After import, the instrument
will be mounted and integrated into a self-service health screening kiosk located in various settings. The
kiosk enclosure, stand, and related hardware are not part of this ruling.
In your letter, you suggest classification under 9018.50.0000, Harmonized Tariff Schedule of the United
States (HTSUS), which provides for other ophthalmic instruments and appliances and parts and accessories
thereof. We disagree. The Explanatory Notes (EN) for heading 9018 lists three categories of ophthalmic
instruments: surgical, diagnostic, and orthoptic or sight testing apparatus. This is an indication that the
drafters of the EN believed that diagnostic apparatus are an identifiable category of ophthalmic instruments.
Subheading 9018.50 describes other ophthalmic instruments and appliances. Thus, other ophthalmic
instruments and apparatus in subheading 9018.50 can include only ophthalmic apparatus which are other than
those provided for at the same subheading level in heading 9018, including an ophthalmic instrument or
apparatus which is an electro-diagnostic apparatus, within subheading 9018.11 through 9018.19. The retinal
imaging instrument is an ophthalmic diagnostic device and more specifically provided in subheading 9
018.19, HTSUS.
The applicable subheading for the retinol imaging instrument will be 9018.19.9550, Harmonized Tariff
Schedule of the United States (HTSUS), which provides for “[i]nstruments and appliances used in medical,
surgical, dental or veterinary sciences …: [e]lectro-diagnostic apparatus …: [o]ther: [o]ther: [o]ther: [o]ther
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 of Taiwan will be
subject to an additional ad valorem rate of duty of 20 percent. At the time of entry, you must report the
Chapter 99 heading applicable to your product classification, 9903.02.60, in addition to subheading
9018.19.9550, HTSUS, listed above.
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)
Denise Faingar
Acting Director
National Commodity Specialist Division