指定 against 株式会社UT-Heart研究所

株式会社UT-Heart研究所 (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=9010901033048&limit=10

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Action summary

Company: 株式会社UT-Heart研究所Japanese original
Original: 株式会社UT-Heart研究所
Corporate Number: 9010901033048
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

Approximately 30% of patients with severe heart failure who underwent cardiac resynchronization therapy (CRT) were reported to have ineffective outcomes, and diagnosing ineffective cases is difficult. The product has novelty and high significance in that it can assist in predicting the effectiveness of CRT. Clinical research (11 cases) reported that the prediction of improvement in cardiac pump function using the product showed a high correlation (correlation coefficient 0.94) with actual effects, indicating high potential efficacy.

Show original Japanese text

心臓再同期療法※を行った重症心不全患者の中で約30％が無効例と報告されており、無効例の診断は困難である。本品は心臓再同期療法の効果予測の判断を補助できる点に新規性があり、画期性が高い。臨床研究（11例）の結果から、本品を使用した心臓のポンプ機能の改善の効果予測は実際の効果と高い相関（相関係数0.94）を示したとの報告があり、高い有効性が期待できる。

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: 2026-04-25T00:13:58.846+00:00
Evidence checked: 2026-04-25T00:13:58.846+00:00
Archive captured: 2026-04-07T12:02:07.09+00:00

Show audit JSON

{
  "record": {
    "id": "3e22c6f2-e456-4ce3-8090-bf5332b2e9d5",
    "url": "https://regbase.jp/en/enforcement/other-ut-heartyan-jiu-suo-20170228",
    "company_name_original": "株式会社UT-Heart研究所",
    "company_name_registry": "株式会社UT-Heart研究所",
    "corporate_number": "9010901033048",
    "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-ut-heartyan-jiu-suo-20170228",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000153128.html",
    "archiveUrl": "https://kiroku.today/view/60d0baf7afokk4is",
    "archiveCapturedAt": "2026-04-07T12:02:07.09+00:00",
    "extractedAt": "2026-04-25T00:13:58.846+00:00",
    "translatedAt": "2026-05-01T07:03:40.964+00:00",
    "evidenceCheckedAt": "2026-04-25T00:13:58.846+00:00",
    "generatedAt": "2026-06-19T10:30:05.709Z"
  },
  "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: 株式会社UT-Heart研究所 Japanese original
Japanese name: 株式会社UT-Heart研究所
Corporate Number: 9010901033048
Registered address: 東京都世田谷区野沢３丁目２５番８号

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