Enforcement record

指定 disclosure naming 株式会社UT-Heart研究所

株式会社UT-Heart研究所 (Pharmaceutical Affairs Act)

This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.

Pharmaceutical Affairs ActMinistry of Health, Labour and WelfareGovernment disclosure28 February 2017

Action type

指定

Law

Pharmaceutical Affairs Act

Authority

Ministry of Health, Labour and Welfare

Action date

28 February 2017

RegBase evidence report

Japanese public-record enforcement check

Saveable record of the published action, regulator source, source status, and review notes for internal compliance files.

Report ID: RB-EN-ENFORCEMENT-OTHER-UT-HEARTYAN-202608041629
Generated at: 5 August 2026 at 01:29
Record URL: https://regbase.jp/en/enforcement/other-ut-heartyan-jiu-suo-20170228

1. Review Summary

Disclosure name	株式会社UT-Heart研究所	Corporate Number	Not stated in the disclosure
Enforcement record	1 record	Other confirmed records for this company	Outside this report's scope
Action date	28 February 2017	Authority	Ministry of Health, Labour and Welfare
Law	Pharmaceutical Affairs Act	Action type	指定
Source status	Preserved public-source archive recorded

This report summarizes public Japanese government disclosure data held by RegBase. It is not a credit score, sanctions conclusion, legal opinion, or adverse-media determination. Confirm important decisions against the linked official Japanese source.

2. Published Information

Published name	株式会社UT-Heart研究所

3. Enforcement Record

Target name in disclosure	株式会社UT-Heart研究所
Authority	Ministry of Health, Labour and Welfare (厚生労働省)
Law / action type	Pharmaceutical Affairs Act / 指定
Action / announcement date	Action: 28 February 2017 / Announcement: 7 April 2026
English summary	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.
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。
Official source	https://www.mhlw.go.jp/stf/houdou/0000153128.html
Source archive	https://kiroku.today/a/60d0baf7afhg2xre
Extraction / evidence timestamps	Extracted: 25 April 2026 at 09:13 / Evidence checked: 25 April 2026 at 09:13 / Archive captured: 12 July 2026 at 16:04

4. Business Location and Permit Details

No additional structured business-location or permit fields are recorded for this disclosure.

5. Other Confirmed Records for This Company

This report covers the single government disclosure shown on this page.

Reviewer Notes

Reviewer		Team / company
Review purpose
Additional notes

□ Official source URL or archived source was checked.
□ Corporate Number, address, or other identifiers were reviewed to avoid confusing similarly named entities.
□ This document is understood as a public-record evidence file, not a credit decision or legal opinion.

Current page: Enforcement record

This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.

Free report

Save the disclosure record naming 株式会社UT-Heart研究所

Includes the published name, regulator, governing law, source links, archive status, and reviewer note fields for internal due-diligence files.

Preserved evidence by Kiroku

Review the preserved source for 株式会社UT-Heart研究所

Open the preserved public source with its capture time, original artifact, available verification data, and downloadable evidence pack.

Open preserved source and evidence pack

For developers: JSON integration details

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/api/v1/enforcements?company=%E6%A0%AA%E5%BC%8F%E4%BC%9A%E7%A4%BEUT-Heart%E7%A0%94%E7%A9%B6%E6%89%80&limit=10

Open JSON Specs

Action summary

Company: 株式会社UT-Heart研究所Japanese only
Original: 株式会社UT-Heart研究所
Governing law: Pharmaceutical Affairs Act
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 Pharmaceutical Affairs Act.

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 source (Japanese)Open preserved source and evidence pack

Extracted at: 2026-04-25T00:13:58.846+00:00
Evidence checked: 2026-04-25T00:13:58.846+00:00
Archive captured: 2026-07-12T07:04:12.296656+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": null,
    "corporate_number": null,
    "law": {
      "ja": "薬事法",
      "en": "Pharmaceutical Affairs Act"
    },
    "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": "unresolved",
    "confidence": 85,
    "method": "nta_strict_name_nationally_unique",
    "method_label": "nta_strict_name_nationally_unique",
    "notes": "NTA full-download lookup found a nationally unique exact registered-name candidate (株式会社ＵＴ－Ｈｅａｒｔ研究所). No Corporate Number was present in the disclosure, so this remains a likely match."
  },
  "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 Pharmaceutical Affairs Act."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-ut-heartyan-jiu-suo-20170228",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000153128.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/60d0baf7afhg2xre",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000153128.html",
    "archiveCapturedAt": "2026-07-12T07:04:12.296656+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": "2026-08-04T16:29:01.392Z"
  },
  "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)

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