CLA-2-90:OT:RR:NC:N3 135

Maeve Shivnan
EOS IT Solutions Inc.
30826 Santana Street
Hayward, CA 94544

RE: The tariff classification of BLOOM43 device from the United Kingdom

Dear Ms. Shivnan:

In your letter dated May 6, 2025, you requested a tariff classification ruling on behalf of PLEXAA Ltd.

BLOOM43 device (Model Number: B4301) packaged in a case is said to be a wearable medical device designed for preoperative preparation for breast surgery. It consists of a bowl-shaped, preconditioning unit connected to a battery via a cable. The preconditioning unit integrates a user interface (a power button, a play button, cycle LEDs, a status LED, and an error LED) on top of the unit and a temperature-controlled heating element inside a plastic housing. The preconditioning unit is intended to be placed within a bra, positioned against the breast skin (ideally centered over the nipple-areola complex), and worn for approximately three hours. It operates in a series of 30-minute active heating cycles within the range of 40°C (104°F) to 44°C (111.2°F), alternating with non-active heating periods. The battery can be securely attached to clothing or carried in a pocket for convenience. BLOOM43 delivers supraphysiological preconditioning to the skin through the application of topical heat, which temporarily improves blood flow circulation. The device measures 138 mm x 175 mm x 50 mm and weighs 435 grams.

The applicable subheading for the BLOOM43 device will be 9018.90.7580, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “[i]nstruments and appliances used in medical, surgical, dental or veterinary sciences …: [o]ther instruments and appliances and parts and accessories thereof: [o]ther: [e]lectro-medical instruments and appliances and parts and accessories thereof: [o]ther: [o]ther:[o]ther.” 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 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 9018.90.7580, 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)
Steven A. Mack
Director
National Commodity Specialist Division