N352128

N352128 August 27, 2025 CLA-2-90:OT:RR:NC:N3:135 CATEGORY: Classification TARIFF NO.: 9018.90.8000; 9903.01.27 Martin Klee Devicor Medical Products, Inc. 300 E-Business Way Cincinnati, OH 45241 RE: The tariff classification of a biopsy site marker in an applicator system from Mexico Dear Mr. Klee: In your letter dated August 7, 2025, you requested a tariff classification ruling. The Mammotome LumiMARK™ Biopsy Site Marker (Internal Part number CA-000622-003) consists of an applicator device (Part number CA-000622) preloaded with a rose-shaped nitinol biopsy site marker (Part number CC-001829-001), packaged in a sterile sealed pouch. The biopsy site marker is a small, self-expanding device made of nitinol, a biocompatible nickel-titanium alloy known for its shape memory and radiopacity. You state that this allows the marker to be easily visualized in follow-up imaging procedures such as mammography, ultrasound, or MRI, facilitating accurate localization of the biopsy site for future diagnostic or surgical interventions. The nitinol shape-memory property allows the insertion of the marker in a small collapsed form that expands after placement. The expanded shapes are easily identified by X-ray or ultrasound. The applicator consists of an insertion cannula with markings made of stainless steel, a plunger assembly, and a handle assembly. In clinical use, the Mammotome LumiMARK™ Biopsy Site Marker is used during a breast biopsy procedure. After tissue is extracted from a suspicious area in the breast using a separate biopsy device (not included in this request), the LumiMARK™ is inserted into the same biopsy site. The applicator may be directly inserted into the tissue or guided through a separate biopsy probe. Ultrasound is usually used to guide the end position of the marker. When in position, the plunger on the applicator device is depressed and the marker is pushed out of the end of the applicator device and is inserted subdermally. Then the applicator device is withdrawn. The applicable subheading for the Mammotome LumiMARK™ Biopsy Site Marker (Internal Part number CA-000622-003) will be 9018.90.8000, Harmonized Tariff System of United States (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: [o]ther instruments and appliances and parts and accessories thereof: [o]ther: [o]ther.” The general rate of duty will be free. Products of Mexico as provided by heading 9903.01.01 in Section XXII, Chapter 99, Subchapter III, U.S. Note 2(a), HTSUS, other than products classifiable under headings 9903.01.02, 9903.01.03, 9903.01.04, and 9903.01.05, HTSUS, will be subject to an additional 25 percent ad valorem rate of duty. At the time of entry, you must report the applicable Chapter 99 heading, i.e. 9903.01.01, in addition to subheadings 9018.90.8000, HTSUS, listed above. Articles that are entered free of duty under the terms of general note 11 to the HTSUS (U.S.-Mexico-Canada Agreement (USMCA)), including any treatment set forth in subchapter XXIII of Chapter 98 and subchapter XXII of chapter 99 of the HTSUS, will not be subject to the additional ad valorem duties provided for in heading 9903.01.01. If your product is entered duty free as originating under the USMCA, you must report heading 9903.01.04, HTSUS, in addition to subheading 9018.90.8000 HTSUS. 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 Mexico are not subject to reciprocal tariffs. At the time of entry, you must report the Chapter 99 heading applicable to your product classification, i.e. 9903.01.27, in addition to subheading 9018.90.8000, 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 fei.chen@cbp.dhs.gov. Sincerely, (for) James Forkan Acting Director National Commodity Specialist Division

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 fei.chen@cbp.dhs.gov. 
Sincerely,
 (for) James Forkan Acting Director National Commodity Specialist Division