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シスメックス 株式会社

シスメックス 株式会社· Corporate Number: 9140001009530

シスメックス株式会社は兵庫県神戸市中央区脇浜海岸通に本店を置く企業である。薬事法に関する公的処分歴が2017年10月に1件記録されている。

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Public Record Summary

Actions in last 3 years
0records
Actions in last year
0records
Latest action
about 8 years ago

5 Oct 2017

Total penalties
-

Repeated actions: 4 actions are recorded for this company. Multiple actions under the same law may be relevant when reviewing repeat compliance issues.

Enforcement and administrative action history

薬事法先駆け審査指定制度対象品目の募集
Confirmed entity match

A cancer-related gene panel testing system that detects gene abnormalities (mutations, amplifications, or fusions) in tumor tissue DNA from solid cancer patients to perform genetic abnormality profiling and assist in treatment decision-making.

5 Oct 2017Ministry of Health, Labour and Welfare
Open source archiveCheck original source
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices先駆け審査指定制度対象品目の募集
RepeatConfirmed entity match

The Ministry of Health, Labour and Welfare established the 'Designated Priority Review System' on April 1, 2015, to promote the development of innovative pharmaceuticals, medical devices, regenerative medicine products, and others, with the aim of facilitating their early practical use in Japan.

5 Oct 2017Ministry of Health, Labour and Welfare
Open source archiveCheck original source
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices指定
RepeatConfirmed entity match

がん関連遺伝子の変異・増幅・融合を網羅的に検査するDNAシークエンサー診断システム。

28 Feb 2017Ministry of Health, Labour and Welfare
Open source archiveCheck original source
薬事法指定
Confirmed entity match

A DNA sequencer diagnostic system that comprehensively tests for mutations, amplifications, and fusions of cancer-related genes, used for genetic abnormality profiling of cancer patients and assisting in clinical decision-making. There are no domestically approved products, and future plans include conducting necessary tests to substantiate the usefulness of cancer-related gene abnormality profiling and submitting an approval application in Japan ahead of the world.

28 Feb 2017Ministry of Health, Labour and Welfare
Open source archiveCheck original source

Language

日本語版を見る (Japanese)

Registry data

English name
シスメックス 株式会社
Japanese name
シスメックス 株式会社
Corporate Number
9140001009530
Registered address
兵庫県神戸市中央区脇浜海岸通１丁目５番１号
Status
Active

Note: This company may not have detailed gBizINFO data, or RegBase has not completed enrichment yet. The public sources below may contain supplemental registry information.

View on gBizINFO ↗View on National Tax Agency Corporate Number site ↗

gBizINFO: fetched 25 Apr 2026

Data sources

Breakdown by law

Breakdown by action type

  • 先駆け審査指定制度対象品目の募集
    2
  • 指定
    2

About this English name

No official English name source is recorded. The original Japanese name is shown.

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