指定 against シスメックス株式会社

シスメックス株式会社 (薬事法)

薬事法Ministry of Health, Labour and WelfareConfirmed entity match28 February 2017

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/api/v1/enforcements?corporate_number=9140001009530&limit=10

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Action summary

Company: シスメックス株式会社Japanese original
Original: シスメックス株式会社
Corporate Number: 9140001009530
Entity match: Confirmed entity match95/100Machine extracted
Normalized Japanese name matched to a company profile with Corporate Number
Matched by normalized Japanese company name to an enriched company profile with a Corporate Number.
Governing law: 薬事法
薬事法
Action type: 指定
指定
Action date: 28 February 2017
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

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.

Show original Japanese text

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であり、がん患者の遺伝子異常プロファイリングを行い、診療方針決定の補助に用いる。国内で承認されたものがなく、今後、がん関連遺伝子異常プロファイリングの有用性を裏付けるために必要な試験を行い、世界に先駆けて日本で承認申請予定。

Compliance context

Context needed

This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.

Japanese regulatory disclosure under 薬事法.

Review the original Japanese source and determine relevance to your counterparty-risk workflow.

This context is an operational aid for review workflows, not a credit opinion or legal conclusion.

Evidence pack

Original Ministry of Health, Labour and Welfare announcement (Japanese)Archived source snapshot

Extracted at: 2026-04-25T00:13:59.114+00:00
Evidence checked: 2026-04-25T00:13:59.114+00:00
Archive captured: 2026-04-07T12:02:08.313+00:00

Show audit JSON

{
  "record": {
    "id": "93131601-30a9-453c-8b20-8b885d6c46d1",
    "url": "https://regbase.jp/en/enforcement/other-sisumetukusu-20170228",
    "company_name_original": "シスメックス株式会社",
    "company_name_registry": "シスメックス 株式会社",
    "corporate_number": "9140001009530",
    "law": {
      "ja": "薬事法",
      "en": "薬事法"
    },
    "action_type": {
      "ja": "指定",
      "en": "指定"
    },
    "authority": {
      "ja": "厚生労働省",
      "en": "Ministry of Health, Labour and Welfare"
    }
  },
  "entity_match": {
    "status": "confirmed",
    "confidence": 95,
    "method": "normalized_name_with_corporate_number",
    "method_label": "Normalized Japanese name matched to a company profile with Corporate Number",
    "notes": "Matched by normalized Japanese company name to an enriched company profile with a Corporate Number."
  },
  "review": {
    "status": "unreviewed",
    "label": "Machine extracted"
  },
  "compliance_context": {
    "severity": "Context needed",
    "actionMeaning": "This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.",
    "practicalNote": "Review the original Japanese source and determine relevance to your counterparty-risk workflow.",
    "lawContext": "Japanese regulatory disclosure under 薬事法."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-sisumetukusu-20170228",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000153128.html",
    "archiveUrl": "https://kiroku.today/view/60d0baf7afokk4is",
    "archiveCapturedAt": "2026-04-07T12:02:08.313+00:00",
    "extractedAt": "2026-04-25T00:13:59.114+00:00",
    "translatedAt": "2026-05-01T07:03:42.556+00:00",
    "evidenceCheckedAt": "2026-04-25T00:13:59.114+00:00",
    "generatedAt": "2026-06-19T10:28:30.120Z"
  },
  "limitations": [
    "RegBase aggregates public Japanese government disclosures and does not provide a credit opinion.",
    "English summaries are provided for reference. The original Japanese source is authoritative.",
    "Possible or unresolved entity matches should be manually verified before use in a decision."
  ]
}

The original Japanese disclosure is the authoritative record. Use possible or unresolved matches only as leads for manual review.

Language

日本語版を見る (Japanese)

Company info

English name: シスメックス株式会社 Japanese original
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

See company profile →

About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.

指定 against シスメックス 株式会社