CLA-2-84:OT:RR:NC:N1:105

Sen Liang
Telesair Inc.
199 Technology Dr., Suite 110
Irvine, CA 92618

RE: The tariff classification of a ventilator filter from China

Dear Mr. Liang:

In your letter dated May 16, 2025, you requested a tariff classification ruling.

The item under consideration is described as the AVEA filter, which is a disposable bacterial/viral filter designed for use with the AVEA ventilator system. The AVEA ventilator system is a critical care ventilator intended to provide continuous mechanical ventilation support to neonatal, pediatric, and adult patients who require invasive or non-invasive ventilatory assistance. This filter is placed in-line with the patient circuit, typically at the expiratory limb or between the ventilator and the patient interface, to protect the internal components of the ventilator from contamination by exhaled air. The filter also prevents cross-contamination between patients and helps maintain the hygiene and operational integrity of the ventilator system.

The HEPA filtration element is a single-use and disposable filter that arrives in an individually wrapped sterile package. It is composed of electrostatic and mechanical filtration media and filters the expired gas down to 0.3 microns. It is said to eliminate 99.999 percent of bacteria and viruses. The filter is specifically designed to fit standard ISO connectors compatible with the AVEA ventilator breathing circuits and has a uniquely shaped plastic housing. The housing allows for efficient flow of air while eliminating harmful contaminants.

The applicable subheading for the AVEA filter will be 8421.39.0115, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Centrifuges, including centrifugal dryers; filtering or purifying machinery and apparatus, for liquids or gases; parts thereof: Filtering or purifying machinery and apparatus for gases: Other: Dust collection and air purification equipment: Other.” The general rate of duty will be free.

Also in your submission, you request consideration of a secondary classification for the AVEA filter under subheading 9817.00.96, HTSUS, which applies to articles and parts of articles specially 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 one's self, performing manual tasks, walking, seeing, hearing, speaking breathing, learning, or working.”

You state that the AVEA filter is uniquely designed with physical features that dedicate its use only with the AVEA ventilator system. While this is true, it is our opinion that the use of a ventilator is not designed for someone suffering from a permanent or chronic physical or mental impairment. Instead, one would use a ventilator for a health condition and may require the use for a few hours, weeks or possibly longer. The length of time would depend on how long it takes for a patient’s lungs to get stronger and to be able to function properly on their own. A ventilator’s purpose is to keep the user breathing while their body fights off an infection or illness or recovers from an injury, after which point the user will no longer need the ventilator.

In our view, the AVEA filter does not satisfy the description set forth in Chapter 98, Subchapter XVII, U.S. Note 4(a) and the secondary classification will not apply to the AVEA filter, under 9817.00.96, HTSUS.

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 8421.39.0115, 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 8421.39.0115, HTSUS, listed above.

Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under subheading 8421.39.0115, 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 9903.88.01 in addition to subheading 8421.39.0115, 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, including information on exclusions and their effective dates, 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.

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)
Steven A. Mack
Director
National Commodity Specialist Division