指定 against 第一医科株式会社

第一医科株式会社 (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=1010001004353&limit=10

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Action summary

Company: 第一医科株式会社Japanese original
Original: 第一医科株式会社
Corporate Number: 1010001004353
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

The device is novel and highly innovative in that it is implanted in the tracheal defect site to maintain the structure of the trachea and serve as a scaffold for mucosal reconstruction. Clinical research (12 cases) suggests high efficacy in all cases, with results indicating the preservation of morphological and functional tracheal functions. After domestic clinical trials, it is planned to apply for approval in Japan ahead of the rest of the world.

Show original Japanese text

気管欠損部位に留置し、気管の構造を保ち粘膜再建の足場となる点に新規性があり、画期性が高い。臨床研究（12例）により、全例で高い有効性を示唆する結果（形態的・機能的に気管としての機能を保っている。）との報告がある。国内での治験を経て、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: 2026-04-25T00:13:58.296+00:00
Evidence checked: 2026-04-25T00:13:58.296+00:00
Archive captured: 2026-04-07T12:02:03.446+00:00

Show audit JSON

{
  "record": {
    "id": "09df882a-0635-4bac-8caf-cc8d59442640",
    "url": "https://regbase.jp/en/enforcement/other-di-yi-yi-ke-20170228",
    "company_name_original": "第一医科株式会社",
    "company_name_registry": "第一医科 株式会社",
    "corporate_number": "1010001004353",
    "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-di-yi-yi-ke-20170228",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000153128.html",
    "archiveUrl": "https://kiroku.today/view/60d0baf7afokk4is",
    "archiveCapturedAt": "2026-04-07T12:02:03.446+00:00",
    "extractedAt": "2026-04-25T00:13:58.296+00:00",
    "translatedAt": "2026-05-01T07:03:37.435+00:00",
    "evidenceCheckedAt": "2026-04-25T00:13:58.296+00:00",
    "generatedAt": "2026-06-19T10:28:59.672Z"
  },
  "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: 第一医科株式会社 Japanese original
Japanese name: 第一医科株式会社
Corporate Number: 1010001004353
Registered address: 東京都文京区本郷２丁目２７番１６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 第一医科 株式会社