Business Suspension Order against 日本メドトロニック株式会社

日本メドトロニック株式会社 (医療機器の自主回収に関する規定)
医療機器の自主回収に関する規定Ministry of Health, Labour and WelfareConfirmed entity match18 February 2021
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/api/v1/enforcements?corporate_number=9010401064015&limit=10

Action summary

Company
Original: 日本メドトロニック株式会社
Corporate Number: 9010401064015
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
医療機器の自主回収に関する規定
医療機器の自主回収に関する規定
Action type
Business Suspension Order
業務停止命令
Action date
18 February 2021
Issuing authority
Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

Product name: Valiant Navion thoracic stent graft system, Quantity subject to recall: 5,194 units, Shipment period: from October 18, 2019 (Reiwa 1) to February 9, 2021 (Reiwa 3).

Show original Japanese text

販売名:Valiant Navion 胸部ステントグラフトシステム、回収対象数量:5194個、出荷時期:令和元年10月18日から令和3年2月9日まで

Compliance context

High

A formal order requiring suspension of business activities for the covered scope or period.

Japanese regulatory disclosure under 医療機器の自主回収に関する規定.

Escalate for legal or third-party risk review before onboarding or continuing a material relationship.

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
2026-04-24T23:36:30.693+00:00
Evidence checked
2026-04-24T23:36:30.693+00:00
Archive captured
2026-04-03T12:31:00.649+00:00
Show audit JSON
{
  "record": {
    "id": "dfc44cfb-0eae-4b6c-bf67-756aba0b2c6c",
    "url": "https://regbase.jp/en/enforcement/other-ri-ben-medotoronituku-20210218",
    "company_name_original": "日本メドトロニック株式会社",
    "company_name_registry": "日本メドトロニック株式会社",
    "corporate_number": "9010401064015",
    "law": {
      "ja": "医療機器の自主回収に関する規定",
      "en": "医療機器の自主回収に関する規定"
    },
    "action_type": {
      "ja": "業務停止命令",
      "en": "Business Suspension Order"
    },
    "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": "High",
    "actionMeaning": "A formal order requiring suspension of business activities for the covered scope or period.",
    "practicalNote": "Escalate for legal or third-party risk review before onboarding or continuing a material relationship.",
    "lawContext": "Japanese regulatory disclosure under 医療機器の自主回収に関する規定."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-ri-ben-medotoronituku-20210218",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_16831.html",
    "archiveUrl": "https://kiroku.today/view/d5912c2a9divtyas",
    "archiveCapturedAt": "2026-04-03T12:31:00.649+00:00",
    "extractedAt": "2026-04-24T23:36:30.693+00:00",
    "translatedAt": "2026-05-01T06:51:18.473+00:00",
    "evidenceCheckedAt": "2026-04-24T23:36:30.693+00:00",
    "generatedAt": "2026-05-20T07:55:09.977Z"
  },
  "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.

Company info

English name
日本メドトロニック株式会社 Japanese original
Japanese name
日本メドトロニック株式会社
Corporate Number
9010401064015
Registered address
東京都港区港南1丁目2番70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.