NEWS RELEASE
1 Nov, 2023

NIPPON KINZOKU's Original Steel Grade “NK-304LCO”

Start of Sales of Stainless Steel Materials forInjection Needles to Europe and China
Compliant with the European Medical Device
Regulations Cobalt Composition Regulations
NIPPON KINZOKU CO., LTD. commercialized “NK-304LCO” stainless steel for injection needles
in November 2020, which is compliant with the Cobalt composition regulation of the European
Medical Devices Regulation (MDR), which came into effect in May 2021 and will be fullytransitioned on 31 December 2028.
We would like to announce that we are currently making progress in expanding sales to overseas
markets.

Insulin needle (typical needle size: 32G)

The MDR is a regulation for marketing medical devices in Europe and is a stricter approvalsystem than the existing Medical Device Directive (MDD). The MDR stipulates the Regulation onClassification, Labeling and Packaging of substances and mixtures (CLP), which targets the cobalt(Co) component contained in stainless steel as a carcinogen. It is less than 0.1%.
Conventional NK-304NKM stainless steel for injection needles was difficult to adapt to thisregulated quantity, but in response to requests from domestic and overseas medical device
manufacturers, we have succeeded in alloy design (composition adjustment) as a result ofdiscussions with raw material manufacturers. We were able to successfully supply the material.
Currently, we have started selling the amount equivalent to approximately 3% of the cobaltregulated materials for customers using our stainless steel material for injection needles. The
complete transition to MDR has been postponed from the original May 2024 to December 2028,
volumes are currently increasing slightly due to the regulatory approach of individual medical
manufacturers, but enquiries from the European and Chinese markets are increasing and sample
shipments have already begun.

The price of NK-304LCO, which complies with Co regulations, is higher than conventional NK304NKM because of the cost of component adjustment at the raw material manufacturer andthe need for steel producing extras. However, we are able to handle small lots in the same way
as NK-304NKM, thereby reducing the burden on the customer as much as possible.
The NK-304NKM has been selected as the material of choice for "thin diameter" types of needles
for insulin such as "painless needles" and cosmetic applications, and is currently being used allover the world. The sales share (*1) of our materials for injection needle applications isapproximately 49% in Japan and 59% overseas (*2), with an average share of approximately
55%, and our quality superiority is widely recognized in the injection needle market. In addition
to maintaining a high market share, sales to the Chinese and Indian markets are expected to
expand in the future due to the increasing number of diabetes patients worldwide.
We humbly accept that the quality of our products, which is born from our unique technology,
and our flexible response to the needs of changing times, will lead to a proven track record andtrust. We are determined to actively take up the challenge of further expanding our sales indomestic and overseas markets.
*1：32 domestic and international companies, surveyed by us in October 2023.
*2：Overseas principal countries are South-East Asia, South Korea, China, India and the EU●Features of the NK-304LCO
1. Processability without rupture even at high drawing rate
Injection needles are manufactured by welding the edge of the material and then stretching
the raw tube into a thin tube. For insulin, for example, a raw tube with a diameter of 4.0mm and a wall thickness of 0.2 mm is drawn, then heat-treated and drawn many times inturn, until it is drawn to an outer diameter of 0.18 mm and a wall thickness of 0.05 mm.
"Processability without rupture even when at high drawing rate" and "Stability of thewelded part of the bare tube that does not fracture even when thinly drawn" are particularly
important in this process.
Our stainless steel for injection needles, “NK-304LCO”, is within the SUS304 composition of
the Japanese Industrial Standards (JIS) and the American Iron and Steel Institute (AISI)
standards, suppresses work hardening and increases processing performance.
2. Stability of the welded part of the bare tube
and cutting surface of the material, which will
not rupture even when thinly drawn.
The ratio between the fractured and sheared
surfaces is agreed to facilitate welding by medical
device manufacturers.
The same end-face properties are supplied forthe entire coil length (0.2 mm: approx. 4,000 M).
（※Reference: Image on the right）【Cutting surface management】
Ratio of sheared surface 50％
Shearedsurface
Fracturedsurface“NK-304NKM”, which is the base of “NK-304LCO”, is a steel grade developed on the premiseof versatility in forming by medical device manufacturers.
＊＊＊Contact＊＊＊
Sales Development Dept.
NIPPON KINZOKU CO., LTD.
E-mail: nikkin-overseas@nipponkinzoku.co.jp
https://www.nipponkinzoku.co.jp/en/inquiry