承認 against アラガン・ジャパン株式会社

アラガン・ジャパン株式会社 (医薬品医療機器等法)

医薬品医療機器等法Ministry of Health, Labour and WelfareConfirmed entity match8 October 2019

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/api/v1/enforcements?corporate_number=9010401085572&limit=10

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Action summary

Company: アラガン・ジャパン株式会社Japanese original
Original: アラガン・ジャパン株式会社
Corporate Number: 9010401085572
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: 医薬品医療機器等法
医薬品医療機器等法
Action type: 承認
承認
Action date: 8 October 2019
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

This product is a skin expander used to facilitate the insertion of artificial breasts during breast reconstruction surgery by embedding it under the skin or pectoral muscle for a certain period to expand and stretch the skin and other tissues around the breast. A component with a smooth surface, 'Natrell 133S Tissue Expander,' has been added. The product is a gel-filled artificial breast used for restoring or shaping the breast during breast reconstruction or augmentation in adult women. To expand the product line of smooth-surfaced variants, the Inspira series has been added to the components.

Show original Japanese text

本品は、乳房再建術時に人工乳房の埋入を容易にするため、事前に乳房皮下又は大胸筋下に一定期間埋め込み、乳房周辺部の皮膚及びその他の組織を拡張・伸展させる皮膚拡張器である。表面をスムーズ加工した構成品「ナトレル133S ティッシュ・エキスパンダー」が追加された。本品は、乳房の形状を修復または形成するために、乳房再建術又は成人女性の乳房増大術に使用されるゲル充填人工乳房である。スムーズ加工の製品バリエーション拡充のため、構成品にInspira シリーズが追加された。

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: 2026-04-25T00:18:14.197+00:00
Evidence checked: 2026-04-25T00:18:14.197+00:00
Archive captured: 2026-04-09T06:00:29.732+00:00

Show audit JSON

{
  "record": {
    "id": "d0a4267d-c20d-4491-b02f-d710f7d6dbe1",
    "url": "https://regbase.jp/en/enforcement/other-araganziyapan-20191008",
    "company_name_original": "アラガン・ジャパン株式会社",
    "company_name_registry": "アラガン・ジャパン株式会社",
    "corporate_number": "9010401085572",
    "law": {
      "ja": "医薬品医療機器等法",
      "en": "医薬品医療機器等法"
    },
    "action_type": {
      "ja": "承認",
      "en": "承認"
    },
    "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 医薬品医療機器等法."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-araganziyapan-20191008",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_07152.html",
    "archiveUrl": "https://kiroku.today/view/d35c7d2bd0r2iuvu",
    "archiveCapturedAt": "2026-04-09T06:00:29.732+00:00",
    "extractedAt": "2026-04-25T00:18:14.197+00:00",
    "translatedAt": "2026-05-01T07:07:03.467+00:00",
    "evidenceCheckedAt": "2026-04-25T00:18:14.197+00:00",
    "generatedAt": "2026-05-22T06:44:50.075Z"
  },
  "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: アラガン・ジャパン株式会社 Japanese original
Japanese name: アラガン・ジャパン株式会社
Corporate Number: 9010401085572
Registered address: 東京都渋谷区恵比寿４丁目２０番３号恵比寿ガーデンプレイスタワー３５階

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.