自主回収 against 旭化成ゾールメディカル株式会社

旭化成ゾールメディカル株式会社 (医薬品医療機器等の品質管理等に関する法律)
医薬品医療機器等の品質管理等に関する法律Ministry of Health, Labour and WelfareConfirmed entity match17 June 2019
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/api/v1/enforcements?corporate_number=1010401101295&limit=10

Action summary

Company
Original: 旭化成ゾールメディカル株式会社
Corporate Number: 1010401101295
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
医薬品医療機器等の品質管理等に関する法律
医薬品医療機器等の品質管理等に関する法律
Action type
自主回収
自主回収
Action date
17 June 2019
Issuing authority
Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

Product names: (1) ZOLL AED Pro semi-automatic defibrillator (2) ZOLL AED Pro semi-automatic defibrillator without manual mode Shipment quantities: (1) 20 units (2) 1 unit Shipment period: from March 5, 2019 to May 31, 2019

Show original Japanese text

販売名:(1)ZOLL AED Pro 半自動除細動機(2)ZOLL AED Pro マニュアルモード無し 半自動除細動機 出荷数量:(1)20台 (2)1台 出荷時期:平成31年3月5日~令和元年5月31日

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 医薬品医療機器等の品質管理等に関する法律.

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
2026-04-25T00:18:04.812+00:00
Evidence checked
2026-04-25T00:18:04.812+00:00
Archive captured
2026-04-09T00:01:20.469+00:00
Show audit JSON
{
  "record": {
    "id": "04dd9728-481e-438b-9b9d-b6856d71fb72",
    "url": "https://regbase.jp/en/enforcement/other-xu-hua-cheng-zorumedeikaru-20190617",
    "company_name_original": "旭化成ゾールメディカル株式会社",
    "company_name_registry": "旭化成ゾールメディカル株式会社",
    "corporate_number": "1010401101295",
    "law": {
      "ja": "医薬品医療機器等の品質管理等に関する法律",
      "en": "医薬品医療機器等の品質管理等に関する法律"
    },
    "action_type": {
      "ja": "自主回収",
      "en": "自主回収"
    },
    "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 医薬品医療機器等の品質管理等に関する法律."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-xu-hua-cheng-zorumedeikaru-20190617",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_05256.html",
    "archiveUrl": "https://kiroku.today/view/ab8673582aqpozcr",
    "archiveCapturedAt": "2026-04-09T00:01:20.469+00:00",
    "extractedAt": "2026-04-25T00:18:04.812+00:00",
    "translatedAt": "2026-05-01T07:06:58.52+00:00",
    "evidenceCheckedAt": "2026-04-25T00:18:04.812+00:00",
    "generatedAt": "2026-05-20T06:27:54.633Z"
  },
  "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
旭化成ゾールメディカル株式会社 Japanese original
Japanese name
旭化成ゾールメディカル株式会社
Corporate Number
1010401101295
Registered address
東京都港区西新橋2丁目1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.