MAR-2:OT:RR:NC:N3:135
Brian Smith
STERIS Corporation
6100 Heisley Rd
Mentor, OH 44060
RE: The country of origin marking of LUMIFLEX 3-Stage Balloon Dilatation Catheter
Dear Mr. Smith:
This is in response to your letter dated July 10, 2025 requesting a ruling on whether your proposed marking
of LUMIFLEX 3-Stage Balloon Dilatation Catheter described below is an acceptable country of origin
marking. Representative images of the labels in the pouch and box were submitted with your letter for
review.
Both labels contain nearly identical information, but their arrangement differs slightly. The country of origin
for this product is China. The country of origin marking on each label is marked with a symbol with “CN”
inside rather than stating “Made in China.” You state this symbol with “CN” is recognized by the Food and
Drug Administration to identify the country of manufacture of products. Among other product information in
each label, it includes the U.S. company’s name, address, phone, and website as shown below:
US Endoscopy
5976 Heisley Road
Mentor, OH 44060
(1)800/549-4873
www.steris.com
A subsidiary of STERIS
Corporation
The marking statute, section 304, Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unless
excepted, every article of foreign origin (or its container) imported into the U.S. shall be marked in a
conspicuous place as legibly, indelibly and permanently as the nature of the article (or its container) will
permit, in such a manner as to indicate to the ultimate purchaser in the U.S. the English name of the country
of origin of the article.
As provided in section 134.41(b), Customs Regulations (19 CFR 134.41(b)), the country of origin marking is
considered conspicuous if the ultimate purchaser in the U.S. is able to find the marking easily and read it
without strain.
With regard to the permanency of a marking, section 134.41(a), Customs Regulations (19 CFR 134.41(a)),
provides that as a general rule marking requirements are best met by marking worked into the article at the
time of manufacture. For example, it is suggested that the country of origin on metal articles be die sunk,
molded in, or etched. However, section 134.44, Customs Regulations (19 CFR 134.44), generally provides
that any marking that is sufficiently permanent so that it will remain on the article until it reaches the ultimate
purchaser unless deliberately removed is acceptable.
In Headquarters Ruling Letter ("HRL") 734487 (May 7, 1992), we noted that CBP has been very stringent in
approving the use of abbreviations to ensure that an abbreviation unmistakably indicates the country of origin
to an ultimate purchaser of a product. In Headquarters Ruling Letter (“HRL”) 735083, dated August 5, 1993,
CBP determined that “NL” is not an acceptable abbreviation for the Netherlands because it does not
unmistakably indicate the country of origin to the ultimate purchaser.” Also, see HRL 562240, dated
February 4, 2002 (denial of “AU” for Australia). Accordingly, using a symbol indicating the origin,
accompanied by the official ISO country code, such as “CN,” is not an acceptable marking to indicate the
country of origin of the product.
Section 134.46, CBP Regulations (19 C.F.R. 134.46), requires that in any case in which the words “United
States,” or “American,” the letters “U.S.A.,” any variation of such words or letters, or the name of any city or
locality in the United States, or the name of any foreign country or locality other than the country or locality
in which the article was manufactured or produced, appears on an imported article or its container, there shall
appear, legibly and permanently, in close proximity to such words, letters, or name, and in at least a
comparable size, the name of the country of origin preceded by “Made in,” “Product of,” or other words of
similar meaning.
The purpose of Section 134.46 is to prevent the possibility of misleading or deceiving the ultimate purchaser
as to the actual origin of the imported goods. In this case, we find that the name and address of the U.S.
company are potentially misleading to the ultimate purchaser as to the country of origin of the good and
trigger the special marking requirements of 19 CFR 134.46. The company name and address on each label
therefore should be accompanied by a statement which includes the name of the actual country of origin
preceded by “Made in,” “Product of,” or other words of similar meaning in close proximity and in lettering of
comparable size. Hence, the proposed marking of the label of the LUMIFLEX 3-Stage Balloon Dilatation
Catheter in the pouch and box, described above, is not an acceptable country of origin marking pursuant to 19
U.S.C. 1304 and 19 CFR 134.
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)
James Forkan
Acting Director
National Commodity Specialist Division